Additional Location(s): N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing - whatever your ambitions.
About the role:
Now is an exciting time to join our Cardiology team as we continue to launch groundbreaking solutions in the Electrophysiology (EP) market-one of the fastest-growing and most innovative areas in medical technology. Boston Scientific offers a comprehensive and integrated portfolio to support the diagnosis and treatment of atrial fibrillation (AFib) and other cardiac arrhythmias. This includes the Opal HDx mapping system, FARAPULSE pulsed field ablation, transeptal access tools, diagnostic and therapeutic catheters, and WATCHMAN FLX left atrial appendage closure devices.
In this field-based leadership role, you will manage and develop a high-performing team of EP Mapping Specialists who provide clinical, technical, and procedural support across these advanced platforms. Your leadership will be instrumental in driving mapping adoption, optimizing procedural outcomes, supporting new technology launches, and ensuring team performance aligns with Boston Scientific's strategic goals. This is a unique opportunity to directly influence patient care, advance innovation in the EP space, and play a key role in shaping the future of cardiac care through thoughtful clinical leadership.
Your responsibilities will include:
* Lead the successful launch of new system placements, including hardware, catheters, and software.
* Assess individual and team training needs to ensure development and certification of EP mapping specialists through structured coaching and final assessments.
* Manage complex scheduling needs and resolve clinical coverage conflicts across geographic boundaries, providing hands-on clinical support and education as needed.
* Champion the introduction of new technologies and drive improvements in mapping utilization and clinical outcomes for existing customers.
* Collaborate closely with the EP Business Development Manager to align clinical goals and initiatives with the broader regional sales strategy.
* Foster a culture of collaboration through consistent communication with direct reports, peers, and leadership including EP Sales Reps, Rhythm Regional Managers, and the Area Sales Director.
* Oversee travel and expense reporting for your team, ensuring timeliness, accuracy, and adherence to company guidelines.
* Ensure compliance with all corporate policies and procedures while fostering a culture of integrity and accountability.
* Partner with key internal stakeholders-including Clinical Research, Marketing, Technical Support, and Sales-to deliver innovative solutions that meet customer needs.
* Lead ongoing education and skill development across the EP clinical team and support execution of company-sponsored events and trainings.
* Conduct performance reviews and provide feedback through regular field visits, mid-year, and annual evaluations.
* Maintain appropriate tools, resources, and staffing to ensure Quality System compliance and adherence to Boston Scientific's Quality Policy.
* Promote an inclusive, high-performance work environment that encourages innovation, teamwork, and continuous improvement.
* Provide strategic oversight and guidance for budgets, team performance, and operational excellence across functional areas.
* Lead by example in promoting diversity, equity, and inclusion, enabling team members to contribute at their highest potential.
* Monitor adherence to regulatory and internal compliance standards, ensuring operational excellence across all activities.
Required qualifications:
* Bachelor's degree and a minimum of 7 years of related experience, or an equivalent combination of education and professional background.
* Demonstrated business acumen with strong analytical and strategic thinking capabilities.
* Proven ability to build relationships and collaborate effectively with internal and external stakeholders across multiple divisions.
Preferred qualifications:
* Knowledge of the local EP customer base and regional market dynamics.
* EP certification and hands-on experience supporting electrophysiology therapies, implants, and related technologies.
* Established leadership presence with the ability to coach, influence, and develop high-performing teams.
* Strong conflict resolution and change management skills.
* Exceptional written and verbal communication abilities.
* Demonstrated success managing complex projects from concept to execution.
* Highly motivated, organized, and goal-driven with a strong sense of ownership.
Requisition ID: 623671
The anticipated annualized base amount or range for this full time position will be $120,000, plus variable compensation governed by the Sales Incentive Compensation Plan (which includes certain annual non-discretionary incentives based on predetermined objectives) as well as the value of core and optional benefits offered at BSC, which can be reviewed at *************************** Actual compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, and other relevant business or organizational needs.
For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.
As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most - united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do - as a global business and as a global corporate citizen.
So, choosing a career with Boston Scientific (NYSE: BSX) isn't just business, it's personal. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!
At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.
Boston Scientific maintains a prohibited substance free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.
Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company's policies or protocols change with regard to COVID-19 vaccination.
Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.
Nearest Major Market: Raleigh
Job Segment: Testing, Compliance, Clinical Research, Medical Research, Electrophysiology, Technology, Legal, Healthcare
$120k yearly 17h ago
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Sales Development Representative (SDR) - Raleigh, NC
Boston Scientific 4.7
Boston Scientific job in Morrisville, NC
Requirements
What you will bring:
Bachelor's degree in business, science or equivalent experience; recent college graduates are encouraged to apply
One year of sales or lab experience preferred
Strong communication skills, both written and verbal, to effectively communicate at all levels of customer organizations and within Genesee
Excellent time management skills with the ability to work independently and as part of a team. Demonstrated ability to collaborate with others to creatively solve problems
Results orientated, strong work ethic and an ability to excel within a rapidly changing and growing organization
Proficient in Microsoft Office Suite applications; experience with a CRM/Salesforce is a plus
Ability to thrive in a fast-paced, collaborative environment and effectively manage multiple priorities
You'll Be a Great Fit If You
Have a desire to learn and grow in sales
Are a self-starter who takes initiative and gets things done
Can handle rejection and see challenges as learning opportunities
Are curious and have a strategic mindset-a desire to understand and offer solutions
Good with technology and excited to work with cutting-edge sales tools
Want a career path in sales with clear growth opportunities
Have prior experience or keen interest in life sciences - lab experience a plus
You do not need prior sales experience- we're looking for potential, not perfection. If you're driven, coachable, and ready to grow, you'll thrive in this role.
Don't let a list of requirements hold you back from applying. If you believe you have the skills, mindset, and drive to excel in this role, we encourage you to apply!
Physical Requirements:
Perform the following tasks, with or without reasonable accommodation:
Primarily sedentary work on a computer at a home office or in a climate-controlled office environment
Regularly sit for extended periods, with occasional standing, walking, and lifting of up to 25 pounds
The role may have limited and periodic overnight travel, i.e. tradeshows, sales meetings, etc.
At Genesee Scientific, you can have a good job that can grow into a great career. We offer:
Training and professional growth initiatives, including comprehensive onboarding programs for new team members
We provide financial well-being with competitive compensation packages and 401 (k) retirement savings plans
Health care and well-being programs including medical, dental, vision, life, short- and long-term disability and employee assistance programs
Paid time off including vacation, sick and 12 holidays
Candidates must be legally authorized to work in the United States without the need for current or future employer sponsorship.
Employment offers are subject to successful completion of a background check and pre-employment drug test.
Genesee Scientific is proud to be an Equal Employment Opportunity employer. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.
Salary Description Starting base salary: $50,000.00 + Commission
$50k yearly 45d ago
Manager, IT Engineering
Gilead Sciences, Inc. 4.5
Raleigh, NC job
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
**Job Description**
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to pursuing scientific invention to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.
You will be part of a team that is helping millions of people live healthier, more fulfilling lives. We are a close community where every individual matters and everyone has a chance to enhance their skills through ongoing development. Inclusion is one of our core values, which means we are creating and fostering a work environment where our differences are valued, and everyone feels respected and empowered to bring their authentic selves to work.
**Summary:**
This role sits within the global Gilead IT organization within the US Commercial Field Enablement IT team with the primary responsibility of supporting IT operations for Field Enablement applications. This role reports to the US Commercial IT Field Enablement lead.
This role will support and liaise with a broad business team including Gilead Commercial Operations, Medical Affairs and Business Conduct. The role will also engage across IT teams who manage/support systems within the Capability ecosystem, i.e., integration touchpoints with tools such as Master Data Management platform and Commercial Analytics Hub as well as the broader IT team that enable the overall working experience for the business teams we support.
This role would act as a liaison between CRM, Events and Account Management capability leads and the vendor MSP teams to manage and deliver on IT operations for field applications. This role would enable Next Gen CRM program by consolidating IT operations for field applications, quickly identifying and mitigating end user impacts and enabling focus on field experience with technology and IT change management.
Some of the key activities that this role would lead include managing IT support operations teams, tracking and reporting on service requests and incidents, providing hands-on support and oversight for complex / priority tickets and escalations, participating in system testing and user acceptance testing, and managing deployment and hypercare.
**Core Tasks, Responsibilities & Scope of Authority:**
+ Utilize ServiceNow to record and track incidents, service requests including report requests
+ Hands-on leadership and execution of IT support operations activities, working with MSP resources
+ Engage with offshore service teams and onshore business and IT partners daily to deliver support operations
+ Build and maintain a track of operational requests over time to advise leadership on trends with a key metric around first call resolution, warm transfers and minimizing field user time spent chasing IT support issues
+ Support field events such as National Sales Meeting with onsite presence when necessary
+ Proactive readiness and planning to support new product launches including onboarding field user groups
+ Support launch of new applications such as Veeva Align, Next Gen CRM, ongoing platform and application enhancements
+ Build and maintain relationships with individual field users and other support groups and product teams
+ Lead IT operations for the field teams in a secure and compliant manner, adhering to appropriate SOPs and work instructions
**Additionally:**
+ Works closely with the respective Product Owners for Veeva / Vault CRM, Events Management, Align and other field applications to ensure end user experience for field applications remains positive
+ Leads operational reporting services delivered within the platform / application using Salesforce / Vault platform reporting, MyInsights / X-Pages
**Basic Qualifications:**
+ Doctorate OR
+ Master's and 4+ years of relevant experience OR
+ Bachelor's and 6+ years of relevant experience OR
**Preferred Qualifications:**
+ Strong techno-functional knowledge of Veeva Commercial Cloud, including but not limited to Align, Veeva / Vault CRM, Veeva Events Management as well as Salesforce platform, Vault platform
+ Strong problem-solving skills, experience in identifying and preventing issues from recurring, debugging and fixing code
+ Ability to prioritize incidents and service requests based on priority levels and knowledge of support escalation paths
+ High level of personal integrity consistent with Gilead's core values (Excellence, Accountability, Teamwork, Integrity and Inclusion)
+ Service-oriented, willingness to put in the extra yards to provide an outstanding experience to end users
+ Experience working in a multi-vendor scenario; vendor management experience is a plus
+ Strong communication skills to engage directly with business users, IT and vendor teams
+ Knowledge of ITIL framework and best practices
+ Knowledge of working with ServiceNow IT service management platform
The salary range for this position is: $126,565.00 - $163,790.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
******************************************************************
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
**For jobs in the United States:**
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' (********************************************** poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (*********************************************************
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
**For Current Gilead Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
$126.6k-163.8k yearly 49d ago
Director, Statistical Programming
Gilead Sciences, Inc. 4.5
Raleigh, NC job
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Job Description
At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.
We set and achieve bold ambitions in our fight against the world's most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come.
Director, Clinical Data Science - SAS Macro and Data Operations leads the end-to-end strategy, development, qualification, and lifecycle management of Statistical Programming tools, macro libraries, applications and automation solutions that accelerate clinical analysis and reporting. The role owns a multi-disciplinary team spanning statistical programming, data engineering, and platform operations, and partners closely with Biostatistics, Clinical Operations, Regulatory, and Quality to ensure compliant, efficient, and scalable delivery. Core technologies include SAS Macros, Python, Linux scripting, and modern cloud services.
Key Responsibilities:
Strategic Leadership & Team Management
* Lead, mentor, and develop a team of SAS macro programmers, data engineers, and application developers (including Linux scripting, Python console, and web applications) to deliver high-quality statistical programming solutions for clinical trials and regulatory submissions.
* Set clear goals, conduct performance assessments, and foster professional growth and continuous learning within the team.
Programming Oversight & Technical Excellence
* Oversee the design, development, validation, and maintenance of SAS macros, scripts, and applications supporting clinical data analysis, reporting, and regulatory deliverables (e.g., SDTM, ADaM datasets, TLFs).
* Ensure programming infrastructure is robust, scalable, and compliant with regulatory standards (e.g., FDA 21 CFR Part 11, GxP), and supports reproducibility and audit readiness.
* Promote automation and standardization of programming workflows to improve efficiency and consistency across studies.
Project Delivery & Resource Management
* Accountable for the timely and quality completion of all programming deliverables across assigned projects and studies, including resource allocation and prioritization.
* Manage project timelines, budgets, and external vendor relationships as needed.
Cross-Functional Collaboration
* Collaborate with Biostatistics, Clinical Data Management, Regulatory Affairs, and IT to define programming requirements, align on analysis/reporting deliverables, and ensure data integrity.
* Represent the statistical programming function in cross-functional meetings and strategic initiatives.
Process Optimization & Innovation
* Lead the development and implementation of programming standards, best practices, and innovative solutions (including cloud-based platforms, AI/ML, and automation pipelines) to enhance efficiency and quality.
* Evaluate and integrate emerging technologies into statistical programming workflows.
Compliance, Documentation & Quality Assurance
* Ensure all programming activities adhere to SOPs, regulatory requirements, and internal quality standards; maintain audit readiness and documentation for all deliverables.
* Oversee code quality, version control, and documentation governance frameworks.
Stakeholder Engagement & Training
* Provide technical guidance and training on advanced programming techniques, tools, and industry trends to team members and stakeholders.
* Act as a key point of contact for external vendors and partners, ensuring alignment on programming standards and deliverables.
Basic Qualifications
PhD / PharmD and 8 years of experience
OR
Master's and 10 years of experience
OR
Bachelor's and 12 years of experience
Preferred Qualifications:
* Education: BS/MS/PhD in Biostatistics, Computer Science, or related field; advanced degree preferred.
* Technical Skills: Expert in SAS Macros and strong proficiency in Python; working knowledge of R and Linux scripting; familiarity with AWS Cloud.
* Core Competencies: Strategic thinking, cross-functional influence, compliance mindset, talent development, user-centric engineering.
People Leader Accountabilities:
* Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
* Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
* Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
The salary range for this position is:
Bay Area: $210,375.00 - $272,250.00.
Raleigh: $181,730.00 - $235,180.00.
Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
******************************************************************
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
For jobs in the United States:
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.
$210.4k-272.3k yearly Auto-Apply 38d ago
Sr. Clinical Specialist, CAS- (Greenville, Fayetteville, Wilmington, New Bern, Raleigh)
Medtronic 4.7
Raleigh, NC job
We anticipate the application window for this opening will close on - 30 Jan 2026 At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
**A Day in the Life**
Bring your talents to a leader in medical technology and healthcare solutions. Rooted in our long history of mission-driven innovation, our medical technologies open doors. We support your growth with the training, mentorship, and guidance you need to own your future success. Join us for a career that changes lives.
CAS seeks collaborative candidates who are patient-centric, passionate, and who represent the same wide variety of life experiences as our patients. We look for candidates who will meet our customer expectations by striving without reserve for the greatest possible reliability and quality in our products, processes and systems by being accountable, having a voice, and taking action.
**This position posting is location flexible and can be based in any of the following locations (Greenville, Fayetteville, Wilmington, New Bern, or Raleigh)**
We are seeking a committed professional to join our team. While this is a remote position not located at a physical Medtronic site, the candidate hired will be required to reside within the territory and drive to multiple accounts throughout the region. A valid driver's license is essential for this role.
**Primary Responsibilities**
+ Provide technical, educational, clinical and sales support to assist the Region in meeting Cardiac Ablation Solutions sales and customer service objectives.
+ Represents Medtronic CAS during ablations procedures to provide troubleshooting and other technical assistance
+ Receives technical inquiries by customers. Researches solutions to questions or problems (e.g., Catheter, Console, Generator support)
+ Educational Support
+ Educates and trains physicians, hospital personnel and office staff on technical matters relating to AFS products and related procedures.
+ One-on-one training sessions
+ In-service education programs
+ Seminars and/or outside symposiums
+ Assists RM and field training department in educating/training new Clinical Specialists and Account Managers
+ Provides training and resources for hospital staff to enable them to conduct training for their personnel
+ Sales Support
+ Updates sales representatives concerning procedure. Immediately notifies Account Manager regarding issues or problems requiring follow-up
+ Serves as effective Medtronic CAS representative to physicians and support staff regarding Medtronic CAS products, service and support
+ Promotes the safe and effective use of Medtronic CAS products and related procedures
+ Understands national, regional and territorysales objectives. Works in partnership with Account Manager to achieve exceed goals
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
We seek out and hire a diverse workforce at every level: We need fresh ideas and inclusive insights to continue to be an innovative industry leader -that's why we make it a point to seek out, attract and develop employees who are patient-centric, passionate, and who represent the same wide variety of life experiences as our patients.
To learn more about Inclusion & Diversity at Medtronic Click Here (*****************************************************************************
**Must Have Minimum Requirements**
To be considered for this role, please ensure these minimum requirements are evident on your resume.
+ High School diploma PLUS a minimum 8 years of work experience in healthcare within an EP, Cath Lab setting or sales in cardiac field
OR
+ Associate degree PLUS a minimum of 6 years of work experience in healthcare within an EP, Cath Lab setting or sales in cardiac field
OR
+ Bachelor degree PLUS a minimum 4 years work experience in healthcare within an EP, Cath Lab setting or sales in cardiac field
**Preferred Qualifications:**
+ Preference will be given to local qualified candidates and candidates with Medtronic experience
+ B.A./B.S. Degree in nursing, cardiovascular, life sciences, or technical discipline with minimum of four years' work experience in cardiac field, hospital/clinic or sales
+ Pacing school/ATI-like training program in addition to BQs
+ Proven track record with technical training assignments
+ Experience in the cardiac catheter ablation field, EP lab, in a hospital/clinic or EP medical sales providing technical / clinical support
**Additional Job Requirements:**
+ Environmental exposure to infectious disease and radiation
+ Clinical Specialists are required to be within their assigned territory each day to be available as unscheduled needs arise
+ Clinical Specialists will on occasion be required to travel outside of their assigned territory and possibility overnight
+ Must have a valid driver's license
+ Ability to freely move throughout the facility, use a phone, keyboard and mouse, visually able to interact with personal computers
+ Must be able to stand/sit/walk for 8 hours a day
+ Must have a valid driver's license
+ Must be able to drive approximately 75% of the time within assigned territory and may require overnight travel.
Must have a valid driver's license and active vehicle insurance policy. In addition, your driving record will be reviewed and will be considered as part of your application.
**CARDIOVASCULAR PORTFOLIO: ** ** **
Cardiac Ablation Solutions offers cardiac mapping and ablation solutions to treat patients with abnormal heart rhythms. Our vision is to help patients worldwide by advancing innovation for the diagnosis and ablation of cardiac arrhythmias, enabling clinicians to perform procedures with superior outcomes.
**Physical Job Requirements**
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
**Benefits & Compensation**
**Medtronic offers a competitive Salary and flexible Benefits Package**
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
Salary ranges for U.S (excl. PR) locations (USD):$100,000.00-$110,000.00
The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).
In addition to Base Salary, this position is eligible for a Sales Incentive Plan (SIP), which provides the opportunity to earn significant incentive compensation for achieving or exceeding your goals.
The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).
Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below:
Medtronic benefits and compensation plans (**************************************************************************************************************
**About Medtronic**
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here (************************* .
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here (*************************************************************************************************************************************** a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
**We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
**We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
**This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will...
+ **Build** a better future, amplifying your impact on the causes that matter to you and the world
+ **Grow** a career reflective of your passion and abilities
+ **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
**Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
**Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
**Better outcomes for our world** . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
**Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here (*********************************** .
For updates on job applications, please go to the candidate login page and sign in to check your application status.
If you need assistance completing your application please email *******************
To request removal of your personal information from our systems please email *****************************
$100k-110k yearly 7d ago
Senior Medical Science Liaison- Autoantibody Pipeline-South
Johnson & Johnson 4.7
Raleigh, NC job
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
Job Function:
Medical Affairs Group
Job Sub Function:
Medical Science Liaison
Job Category:
Scientific/Technology
All Job Posting Locations:
Nashville, Tennessee, United States, Raleigh, North Carolina, United States
Job Description:
Johnson & Johnson Innovative Medicine is searching for the best talent for a Senior Medical Science Liaison- Autoantibody Pipeline for the South region. This is a field-based position located in the South region, the preferred location is the Raleigh, NC or Nashville, TN area. The territory covers Louisiana, Arkansas, Mississippi, Kentucky, Tennessee, North Carolina, South Carolina, and Virginia.
About Immunology
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Our Immunology team leads in the development of transformational medicines for immunological disorders and illnesses. You can influence where medicine is going by restoring health to millions of people living with immune diseases. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at *******************/innovative-medicine.
The Senior Medical Science Liaison (Sr. MSL) is responsible for providing fair balanced, objective, scientific information and education to opinion leaders (OLs), health care professionals, and to internal partners as required by scientific and business needs. The Sr. MSL is considered an established scientific and clinical knowledge lead on current and future J&J Innovative Medicine products per Therapeutic Area (TA) alignment. Sr. MSL is responsible for staying abreast of current scientific and treatment landscape trends in their therapeutic areas of interest. Sr. MSL provides research support for company and investigator-initiated research. The Sr MSL will function with high integrity and follow credo values.
Sr. MSL is responsible for building external relationships with identified OLs and health care providers (MD, DO, PhD, PA, NP, RN, Pharm.D., bio coordinators) and developing and managing a geographical territory. These relationships and engagements can include both virtual & in-person, with a prioritization of in-person engagements when appropriate.
The Sr. MSL is responsible for developing and maintaining a territory strategic plan, which includes educational activities with identified OLs, HCPs, institutions, and community practices.
The Sr. MSL role is one that requires a level of competency and experience in the disease state. The Sr. MSL is expected to possess foundational competencies in the areas of Influence & Results Focused, Communication, Stakeholder Engagement, Product & Therapeutic Area Knowledge, and Data Insights & Dissemination.
The Sr. MSL will be expected to rapidly identify and compliantly collaborate with field-based partners to ensure support of the Healthcare Providers, which will positively impact the patients that they care for.
The Sr. MSL will continue to enhance their skills in agility, applying the competencies of Change Management, Time Management and Innovation.
The Sr. MSL is responsible for conducting all activities in accordance with current regulatory and health care compliance guidelines.
This is a field based clinical position which required travel, primarily throughout assigned geography, with infrequent meeting travel outside of assigned geography. Travel for this role is estimated at 70%.
Responsibilities:
Consistently demonstrate strategic territory planning and ability to build strong relationships within the territory.
* Responsible for developing and maintaining a field strategic plan.
* Responds in a timely manner to unsolicited scientific inquiries of HCPs/investigators/health care systems/academic medical centers and population health decision makers integrating scientific data including real world evidence into real life practice to meet customer needs.
* Presents data and information in a manner appropriate to the audience and request.
* Execute plans regarding reactive and proactive outreaches as approved via the legal/HCC exceptions process.
* Integrates scientific data into real life practice to meet customer/audience needs, adapting interpersonal style to particular situations and people.
* Anticipates the responses of various individuals and teams based on their vantage point and perspective.
* Prioritize franchise customer-based initiatives and field responsibilities, while balancing administrative duties and project responsibilities.
* Executes Research Initiatives:
* Leverages knowledge of standards of care and Janssen company/investigator sponsored clinical trials and competitor landscape to facilitate external-internal research communication.
* Engages with external investigators regarding unsolicited research inquiries and act as liaison to R&D, Medical Affairs and operations teams.
* Provides clinical trial support to identify potential sites, resolve issues with enrolled sites, and participate in meetings as appropriate, including site initiation visits and investigator launch meetings.
* Effectively leads at least one scientific or strategic Immunology project, exhibits strategic identification of educational gaps and elevates team acumen.
Consistently demonstrates strong scientific acumen.
* Actively participate in team calls, trainings, & journal clubs through scientific dialogue, understanding of current standard of care, and regularly sharing of scientific news.
* Attends and provides leadership at scientific conferences to gather and understand new scientific information relevant to the company and the external scientific community.
* Medical insights: Actively listens for, documents, and shares medical insights. Proactively synthesize data and medical insights for MSL team and other partners
* Sets aside time for self-driven learnings on current scientific landscape.
* Role includes representing and supporting JNJ at relevant scientific or other key stakeholder meetings including congresses, symposia, advisory boards and investigator meetings.
* Role includes representing JNJ at speaking engagements at relevant scientific or other key stakeholder meetings.
Continuous support Department Operations and Internal Partners:
* Performs all administrative requirements in a timely, accurate and compliant manner (e.g. expense reports, documentation of activities)
* Maintain focus and composure in uncertain circumstances with minimal direction.
* Provide regional and local support to enhance sales training initiatives and improve competencies of field personnel in partnership with Sales Learning and Development
* Communicates and collaborates with all field-based partners, and other Immunology MSL teams on a routine basis.
* Demonstrate the ability to partner with others to lead or participate in large scale projects.
* Maintains thorough understanding and competence in the following areas (regulatory and health care compliance guidelines; corporate policies on appropriate business conduct and ethical behavior; Medical Affairs SOPs and guidelines.
Qualifications
Required:
A PharmD, PhD, MD, w/ 3+ years relevant hematology, immunology and/or auto/alloimmune disease experience
Minimum 3 years MSL experience, and/or 2-3 years relevant work exp (clinical or research experience)
Must be familiar with Microsoft Word, Excel, PowerPoint, and utilization of computers and remote technologies.
Ability to travel up to 70 %.
Preferred:
Launch experience in rare disease is highly preferred.
Significant experience giving presentations is highly preferred.
Must be familiar with Microsoft Word, Excel, PowerPoint, and utilization of computers and remote technologies.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers and internal employees contact AskGS to be directed to your accommodation resource.
#LI-Remote
Required Skills:
Preferred Skills:
Analytics Dashboards, Clinical Research and Regulations, Clinical Trials, Consulting, Customer Centricity, Data-Driven Decision Making, Digital Culture, Digital Literacy, Medical Affairs, Medical Communications, Medical Compliance, Mentorship, Product Knowledge, Relationship Building, Research and Development, Strategic Thinking, Tactical Planning, Technical Credibility
$90k-126k yearly est. Auto-Apply 17d ago
Patient Experience Supervisor - PSC
Johnson & Johnson 4.7
Raleigh, NC job
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
Job Function:
Customer Management
Job Sub Function:
Customer Service Operations
Job Category:
People Leader
All Job Posting Locations:
Charlotte, North Carolina, United States, Dallas, Texas, United States, Fort Worth, Texas, United States, Orlando, Florida, United States of America, Phoenix, Arizona, United States, Pittsburgh, Pennsylvania, United States of America, Raleigh, North Carolina, United States
Job Description:
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at *******************/innovative-medicine
We are searching for the best talent for a Patient Experience Supervisor for Patient Service Center (PSC) located in Pittsburgh, PA; Raleigh, NC; Charlotte, NC; Orlando, FL; Dallas/Fort Worth, TX; or Phoenix, AZ.
Purpose:
The Patient Experience Supervisor will oversee daily operations, ensure superior service delivery, and support a team of direct reports. You will play a critical role in enhancing the efficiency and effectiveness of our healthcare operations, ensuring we meet the needs of our patients while maintaining the highest standards of quality and compliance.
Responsibilities:
* Supervise, coach, and mentor a team of direct reports, ensuring excellent patient service.
* Oversee the onboarding of new hires, and identify training needs to enhance ongoing skills and productivity. Collaborate with training leadership for upskilling.
* Monitor team performance through key performance indicators (KPIs) and metrics, conduct regular performance discussions, set performance goals, and ensure team compliance with policies and healthcare regulations (e.g. HIPAA)
* Work closely with leadership and key business partners to achieve program goals, develop SOPs and ensure compliance.
* Manage staff scheduling and maintain data quality standards based on program metrics.
* Implement and enhance operational processes for accuracy and efficiency.
* Review and update scorecards to align with call guides for programs as required.
* Partner with leadership to create and implement quality assurance measures ensuring adherence to processes, procedures, and patient confidentiality.
* Resolve escalated operations leadership concerns promptly, ensuring timely resolutions and maintaining patient satisfaction.
* Track operational metrics, deliver regular reports and updates to management and stakeholders,
* Recommend workflow, system, and process improvements to enhance efficiency, productivity, and overall program performance.
* Work with cross-functional teams to implement new strategies and best practices.
* Up to 10% travel may be required.
* Other duties as assigned.
Required Qualifications:
* Bachelor's Degree in Healthcare Administration, Business Management or related field or equivalent experience.
* Minimum of 4 years' working experience with 3 years' experience in a supervisory role in a call center environment, ideally within the healthcare industry. Strong understanding of call center operations, call and documentation quality monitoring, KPIs, and healthcare regulations.
* Proven leadership skills with the ability to inspire and motivate a team, while also maintaining accountability.
* Proficient with using call center software, CRM tools, and Microsoft Office Suite.
Preferred Qualifications:
* Proficient with using call center software, CRM tools, and Microsoft Office Suite.
* Ability to manage deliverables in a fast-paced environment.
* Exceptional customer focus, collaboration, initiative, results-oriented, business solution-oriented capabilities
#Li-Remote
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills:
Consulting, Customer Analytics, Customer Centricity, Customer Engagement, Customer Relationship Management (CRM), Customer Support Operations, Customer Support Platforms, Customer Support Policies and Procedures, Customer Support Trends, Developing Others, Inclusive Leadership, Leadership, Problem Solving, Process Optimization, Quality Services, Service Excellence, Standard Operating Procedure (SOP)
$52k-71k yearly est. Auto-Apply 2d ago
Manufacturing Execution System (MES) -Lead
J&J Family of Companies 4.7
Wilson, NC job
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
**Job Function:**
Supply Chain Engineering
**Job Sub** **Function:**
Automation Engineering
**Job Category:**
People Leader
**All Job Posting Locations:**
Wilson, North Carolina, United States of America
**Job Description:**
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at *******************/innovative-medicine .
J&J is expanding our manufacturing capacity with $2 billion investment to support strong portfolio growth and continue delivering breakthrough innovation and transformational medicines for patients. The new facility will expand production of innovative biologic medicines in areas including oncology, immunology, and neuroscience. J&J's significant supply chain investment ensures a resilient and reliable future supply of medicines to meet accelerating demand for our current portfolio of medicines and our future innovations.
The GET (Global Engineering & Technology) organization operates as one integrated team in the delivery of Engineering, Maintenance and Execution Systems solutions. We operate in a standard, coordinated and consistent manner in support of the current and future requirements of our Manufacturing and Manufacturing Science and Technology (MSAT) and in partnership with key internal/external network.
Apply today for this great opportunity located in Wilson, NC!
The MES Lead drives the design and configuration activities of site's Kroeber PAS-X MES, including MBR design, vendor management, production, validation and development systems, system standards, and interfaces to DCS & IT systems.
The new facility and the production process are envisioned to be highly automated with data being shared across multiple platforms to support production, from raw material receipt to disposition of the produced drug substance. Data generated at each stage of production will be shared across business information and control systems, including the multivariate analysis to support predicative models for process control and disposition support.
**Key Responsibilities:**
+ lead the design, deployment and continues improvement of site MES
+ Oversee technical team of vendors and contractors to ensure requirements are implemented and tested correctly
+ Collaborate cross-functionally with Manufacturing, Quality, Engineering, and IT to identify and implement digital solutions that enhance productivity and data accuracy.
+ Lead the planning, execution, and completion of MES application configuration activities like MBR, item management, equipment management, label management from start to finish. This includes defining project scope, creating technical designs, and managing project execution.
+ Work hand on hard with IT in seamless integration of the MES with other enterprise and shop floor systems, such as ERP, SCADA, and LIMS, to enable real-time data flow.
+ Provide in-depth technical support and troubleshooting for MES-related issues, including troubleshooting configuration errors, and integration challenges with DeltaV. Develop and maintain technical documentation.
+ Ensure that site and global standards are met.
+ Lead risk assessments.
+ Support GMP audits.
**Qualifications**
**Education:**
+ Bachelor's degree in engineering, IT, Science or related field; required
**Experience and Skills:**
**Required:**
+ A minimum of 8 years of experience in a manufacturing environment, biopharmaceutical or pharmaceutical industry, or an equivalent combination of education and experience
+ In-depth knowledge of MES platforms (e.g., Werum PAS-X) and interfaces to IT and DCS.
+ Proficiency in MES software platforms, with strong programming skills in areas like .NET, SQL, PL/SQL, and Java. Expertise with OPC servers and clients for data exchange is also valuable.
+ Strong analytical and problem-solving skills to handle complex technical challenges and provide effective solutions.
+ Proven ability to lead technical teams, manage projects, and mentor junior engineers.
+ Excellent communication skills to effectively present technical information to both technical and non-technical audiences, and to gather requirements from clients.
+ Knowledge of cGMP regulations related to CSV including 21 CFR Part 11 and EU GMP Annex 11.
+ Proven experience within a pharmaceutical or GMP regulated manufacturing environment
+ Experience in supervision/management of people and resources.
+ Process knowledge for Upstream, Downstream and Bio Processing Support functions.
**Preferred:**
+ Good appreciation of Industry 4.0/IoT
+ Experience in integrating MES system with DeltaV PAS & OSI PI data historian
+ Good understanding of batch release reports and release by exception
**Other:**
+ _Ability to travel up to 10% of the time, domestic and internationally_
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit ******************* .]
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.
**Required Skills:**
Computer System Validation (CSV)
**Preferred Skills:**
$70k-90k yearly est. 60d+ ago
Quality Director
J&J Family of Companies 4.7
Wilson, NC job
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
**Job Function:**
Quality
**Job Sub** **Function:**
Multi-Family Quality
**Job Category:**
People Leader
**All Job Posting Locations:**
Wilson, North Carolina, United States of America
**Job Description:**
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at *******************/innovative-medicine
We are currently seeking a Quality Director to join the Quality Team in Wilson, North Carolina.
While this role will ultimately support the site operations located in Wilson NC, this role will also be required to support the project phase across both design & construction. For the project design phase, the role will require you to be present with our design teams in the Greater Philadelphia region. Once the design phase is completed, this role will support the construction and operational start-up of the site. For this, you will be required to be on site in Wilson, NC. Based on your current location the hiring team will work with you to determine travel and relocation arrangements. In steady state, we expect travel to be less than 10%.
J&J is expanding our manufacturing capacity with $2 billion investment to support strong portfolio growth and continue delivering breakthrough innovation and transformational medicines for patients. The new facility will expand production of innovative biologic medicines in areas including oncology, immunology, and neuroscience. J&J's significant supply chain investment ensures a resilient and reliable future supply of medicines to meet accelerating demand for our current portfolio of medicines and our future innovations.
This Quality Director is responsible for leading and managing all Quality related programs and activities to support manufacturing operations. These functions and activities include Quality Control testing, Quality Assurance review and approval functions, Compliance activities, Product Release activities, etc. This role has the authority to make decisions in the following areas:
+ Disposition of all incoming materials (incoming drug substance, excipients, components, packaging materials, etc.) and materials manufactured in the facilities at the site.
+ Decisions with respect to Quality and Compliance.
+ Reporting the Performance of the Quality System.
The initial 5 years of this role will predominantly focus on leading/directing all Quality aspects in completing the conceptual design, basis of design, detailed design, construction, commissioning/qualification, process validation, and regulatory submission/approval for this new U.S.-based Biotherapeutic manufacturing facility.
**Key Responsibilities:**
+ Provide overall Quality leadership and guidance to all site functional areas and management teams to ensure that business goals are achieved in compliance with all regulations and with a high level of quality meeting Johnson & Johnson's Quality Policy Standards.
+ Develop and champion a Quality culture that promotes behaviors that lead to superior business performance and organizational excellence.
+ Partner with peers in equivalent roles at other Innovative Medicine Supply Chain Sites to ensure harmonization and alignment with Innovative Medicine Supply Chain Quality Policies, Guidelines, Programs and Systems.
+ Responsible for appropriately staffing and developing the Quality organization to meet business needs and succession plans. This includes mentoring and coaching staff as well as developing and implementing training programs, to ensure professional and personal development of department personnel.
+ Ensures financial leadership by developing appropriate operating and capital expense budgets.
**Qualifications:**
+ Requires a minimum of a bachelor's degree in science, Pharmaceutical Engineering, Engineering, Pharmacy, Biochemistry, Microbiology, Biology, Chemistry or Molecular Biology. Advanced degree in a scientific or engineering discipline is preferred.
**Required Years of Related Experience:**
+ 10-15 years' experience in a significant leadership position within the biological and/or pharmaceutical industry and 5 years' experience in a Quality leadership role required.
+ Experience & Interaction with FDA/EMEA regulatory requirements applicable to biologics or pharmaceuticals.
+ Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
+ Proven success in managing within a global organization.
+ Strong knowledge in regulatory compliance, Quality Systems, pharmaceutical industry, pharmaceutical methods and procedures and experience with regulatory inspections.
+ Quality management skills: problem solving, statistical thinking, design of experiments, etc.
+ Relationship skills: negotiation skills, presentation skills, able to read the corporate culture, listening skills, harvests people's energy, and manages diverse team members.
+ Excellent interpersonal skills.
+ Innovative, tenacious, and passionate about quality.
+ Time management skills.
+ Attention to detail without losing sight of the big picture.
+ Keeps up to date with technical and managerial developments in the industry.
+ Results and performance driven.
+ Proven success as a People Leader.
+ Adaptable and flexible.
+ An unquestionable level of integrity and commitment to operating ethically and within the boundaries of regulatory requirements.
+ Empowered professional who can make well motivated pragmatic decisions on his/her own.
+ Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and communicate complex quality concepts to stakeholders at all levels.
+ Demonstrated ability to drive change, lead cross-functional teams, and promote a culture of quality consciousness.
+ Detail-oriented mindset, with a keen eye for identifying opportunities for process improvements.
+ Proven ability to manage multiple priorities and work independently with minimal supervision.
+ The ability to work in a team environment and interact with all levels of the organization.
+ Serve as a role model for making Credo-based decisions, helping others understand the value of Credo-based decisions.
+ Support the creation of a trusting, collaborative, and ethical work environment that positively contributes to employee engagement.
+ Maintains the highest standards of ethics, quality, compliance and accountability.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (********************************) or contact AskGS to be directed to your accommodation resource.
**Required Skills:**
**Preferred Skills:**
$132k-165k yearly est. 15d ago
Account Executive - Raleigh, NC - Johnson & Johnson MedTech - Surgical Vision
Johnson & Johnson 4.7
Raleigh, NC job
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
Job Function:
MedTech Sales
Job Sub Function:
Clinical Sales - Specialty Physicians (Commission)
Job Category:
Professional
All Job Posting Locations:
Raleigh, North Carolina, United States
Job Description:
We are searching for the best talent for an Account Executive covering Durham, Raleigh, New Bern, Fayetteville, Greeneville, and Rocky Mount, NC territory.
About Vision
Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.
Are you passionate about improving and expanding on the possibilities of vision treatments? Ready to join a team that's reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life. Our products and services address these needs - from the pediatric to aging eye - in a patient's lifetime. Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech
The Account Executive represents AMO Sales and Services, Inc. to appropriate customer base within a designated geographical area, placing major emphasis on increasing sales of Monofocal and Refractive IOL's, Phaco, OVD, adjunct products and any other new technologies. Assigned sales goals are achieved through creative, consultative selling and implementation of the U.S. marketing plans. The Account Executive provides technical product knowledge and in-service support to ensure customer satisfaction. Effectively utilizes all Johnson & Johnson sales specialists to enhance productivity and provide optimal customer satisfaction. Works synergistically with all other Johnson & Johnson sales personnel in additional SBUs in co-selling efforts to strengthen Johnson & Johnson customer value. Complies with required reports and requests, effectively manages Johnson & Johnson field assets to include consigned products, surgical instruments, surgical equipment, sales force automation, ancillary items, and operates territory within budgetary guidelines.
Core Job Responsibilities
* Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
* Achieves assigned sales goals through execution of U.S. marketing plans. Demonstrates an independent, creative, and consultative/value based sales approach to selling IOLs, Phaco equipment, viscoelastics and surgical adjuncts. Works synergistically with Laser Vision Correction Group counterparts as a means of providing customers with a full product solution. Selling time for IOLs, Phaco and adjuncts are consistent with current year marketing plan.
* Provides expert product knowledge with regard to surgical and refractive techniques, technical product support, in-service programs and innovative educational programs. Prepares and provides detailed sales/procedural/financial presentations to new and existing customers.
* Leverages and effectively utilizes all other Johnson & Johnson's resources and sales personnel and strategic partners to enhance field productivity. This includes integration of the Phaco in-service, innovative educational programs and CORE.
* Utilizes Customer Resource Management System and computer hardware/software to enhance productivity. Prepares and submits on a timely basis all reports requested by management and marketing through use of email.
* Effectively manages Johnson & Johnson's field assets to include IOL consignments (achieve target consignment ratios), product samples (within assigned budget), surgical instruments, Phaco demonstration equipment/accessories and computer hardware/software.
Position Accountability / Scope
* Reports directly to the District Manager (DM) or Senior District Manager (SDM) assigned to that territory. Has responsibility of hitting an established quota set for that territory for all disposable, capital, and other surgical and non-surgical products. Must manage a budget for Travel and Expenses as well as manage a budget for the territory. All other consigned lenses, trunk stock, literature, and surgical equipment will be the responsibility of the AE to manage the assets appropriately. The AE will be expected to call on all Ophthalmologists and staff within the assigned territory to grow the market share of that area, as well as to maintain the current base of business.
* Must be able to work independently, as well as part of a team and support company goals and sales objectives.
* 35%- 40%-overnight travel.
Qualifications
* Bachelor's degree from an accredited college/university or 7 years of relevant experience as it relates to the role.
* 3 years of professional selling experience is required.
* Surgical O.R. experience is preferred but not required.
* Must be able to work independently, as well as part of a team and support company goals and sales objectives.
* The ability to travel, which may include overnight / weekend travel is required.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource.
At Johnson & Johnson, we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear, fair, and respectful of your time.
Here's what you can expect:
* Application review: We'll carefully review your CV to see how your skills and experience align with the role.
* Getting to know you: If there's a good match, you'll be invited to complete a short-recorded video interview, giving you the chance to share more about yourself. If successful, a recruiter will also reach out by phone to walk you through the process and answer any questions.
* Interviews with the team: If you move forward, you'll meet with the hiring manager (and possibly others on the team) in one or two interview rounds, depending on the role.
* Staying informed: We know waiting can be hard, so our recruitment team will keep you updated and make sure you know what to expect at each step.
* Final steps: For successful candidates, you will need to complete country-specific checks before starting your new role. We will help guide you through these.
At the end of the process, we'll also invite you to share feedback in a short survey - your input helps us continue improving the experience for future candidates. Thank you for considering a career with Johnson & Johnson. We're excited to learn more about you and wish you the best of luck in the process! #RPONA
Required Skills:
Preferred Skills:
$66k-93k yearly est. Auto-Apply 1d ago
QA Specialist, C&Q/CSV
Johnson & Johnson 4.7
Wilson, NC job
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
Job Function:
Quality
Job Sub Function:
Quality Assurance
Job Category:
Professional
All Job Posting Locations:
Wilson, North Carolina, United States of America
:
The purpose of this document is to outline the job description of the QA Specialist at Janssen Biotech, Inc in Wilson, North Carolina.
The employee is acquainted with the annual company and division goals and is aware of how he/she can influence these through his/her performance.
Essential Job Duties and Responsibilities
This position is responsible for ensuring compliance with regulatory requirements and company policies following current Good Manufacturing Practices, Johnson & Johnson Policies and internal procedures through the following duties and responsibilities:
* Ensure the site validation program has been developed and maintained in compliance with all regulatory and corporate requirements and Master Plans.
* Works with the applicable qualification teams representing Quality Assurance in the requirement, design review, construction, qualification and leveraging documentation strategies, cleaning development/validation and implementation of project.
* Review and approve commissioning and qualification documentation, including URS (User Requirements Specifications), IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) protocols and reports, SOP's, Work Instructions and any other technical document.
* Review and approves validation protocols and reports (analytical, cleaning, process, etc.)
* Provide quality oversight for C&Q/CSV and validation execution activities to ensure compliance with GMP, FDA, EMA, and other regulatory requirements.
* Support the development and implementation of C&Q and validation plans, ensuring alignment with project timelines and deliverables.
* Perform QA reviews of system impact assessments and categorization of equipment and utilities.
* Ensure compliance with company quality standards, including SOPs, work instructions, and quality policies.
* Act as the QA point of contact for deviations, CAPAs, and change controls related to C&Q and validation activities.
* Provide recommendations for process improvements to enhance compliance and efficiency in C&Q and validation activities.
* Reviews/approves Technology Transfer documents assuring they meet regulatory and J&J requirements.
* Collaborate with cross-functional teams, including engineering, validation, and manufacturing, to address quality issues.
Additional Job Duties and Responsibilities:
* Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met following the J&J Standards.
* Partners with other Departments to ensure that compliance systems are implemented in an efficient manner.
* Develops and implements processes, procedures, forms, work instructions and tools related to the implementation of compliance systems at the site.
* Carries out tasks related to the administration of site nonconformance management, change control and training systems and its applicable Electronic Tracking System (ETS).
* Develops and implements processes, procedures and tools related to the implementation of compliance systems at the site.
* Collaborate with cross-functional teams (Operations, Engineering & Maintenance, MSAT, QC, etc) to address quality issues.
* Provides support to documentation review through evaluation and approval of documentation related to regulatory submissions, standard operating procedures (SOPs), and quality management systems to ensure accuracy and compliance as required.
Minimum Qualification
* Bachelor's degree in a scientific or engineering discipline is required.
* Two to four (2-4) years of experience working within the biotherapeutic and/or pharmaceutical industry and knowledge in compliance of commissioning, qualification and validation of GMP processes and systems such as Utilities (water for injection, clean steam, process gases, HVAC, SIP/CIP), fridges, freezers, LAF, BSC units, autoclaves and isolators - as well as Process Equipment - Bioreactors, UF/DF, centrifuge, Chromatography systems.
* Strong understanding of cGMP, FDA, EMA, ICH guidelines, and ISPE Baseline Guides. Hands-on experience with qualification/validation lifecycle (URS, FAT, SAT, IQ, OQ, PQ) and cleaning/process validation.
* Familiarity with ISPE guidelines, including GAMP 5, ASTM E2500, and validation lifecycle principles.
* Strong understanding of risk-based approaches to commissioning and qualification/validation.
* Proficiency in technical writing for validation and quality documents.
* Strong communication and interpersonal skills for cross-functional collaboration.
Other requirements
* An unquestionable level of integrity and commitment to operating ethically and within the boundaries of regulatory requirements.
* Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams.
* Proven ability to manage multiple priorities and work independently with minimal supervision.
* Detail-oriented mindset, with a keen eye for identifying opportunities for process improvements.
* Proven ability to prioritize tasks and meet deadlines in a dynamic manufacturing environment.
* Ability to build and nurture strong and positive relationships.
* The ability to work in a team environment and interact with all levels of the organization.
Required Skills:
Preferred Skills:
Business Alignment, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail-Oriented, Goal Attainment, Human-Centered Design, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards
The anticipated base pay range for this position is :
$79,000.00 - $127,650.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
For additional general information on Company benefits, please go to: - *********************************************
This position is eligible to participate in the Company's long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation -120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
Holiday pay, including Floating Holidays -13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave - 80 hours in a 52-week rolling period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
$79k-127.7k yearly Auto-Apply 17h ago
Sr. Principal Engineer, Area System Owner (1 of 2)
Johnson & Johnson 4.7
Wilson, NC job
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
Job Function:
Supply Chain Engineering
Job Sub Function:
Process Engineering
Job Category:
Scientific/Technology
All Job Posting Locations:
Wilson, North Carolina, United States of America
Job Description:
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at *******************/innovative-medicine
We, the MTO are responsible for supplying medicines to markets around the world. With Quality as our primary focus, our group strives to provide access and affordability through innovation and strong collaboration with our R&D and Commercial partners to deliver life changing solutions for patients in need.
Support the deployment of the MTO aspiration "to innovate to safely supply quality products and services competitively, faster, always". Responsible for providing advanced engineering design and start-up of GMP large molecule biologics manufacturing facilities, systems, and equipment; and providing engineering and technical/business support for new complex process equipment and systems. Provide integrated equipment, utility, and facility engineering expertise with an operational and maintenance focus in support of manufacturing projects to support 'right first time' execution and start up.
Apply today for this exciting opportunity to be part of our growing team!
Management to drive innovative solutions in engineering support, and process technology. Coordinate with internal stakeholders to ensure project alignment with technology standards and engineering specifications for GMP manufacturing. Provide technical mentoring, building high-performing utility or process engineering team.
Key Responsibilities:
* Extensive interaction with external partners (A&E, construction firms, equipment vendors) to develop, organize and execute project plans as SME and utilities systems owner. The incumbent should demonstrate the following: detail and goal oriented, teamwork, customer-focus, thorough understanding of GMPs and regulatory requirements.
* Serve as Process Engineering Expert (Utilities, Process Systems) to develop business based technology solutions and provide integrated process equipment, utility and facility engineering expertise with an operational and maintenance focus to support execution of strategic and key CAPEX manufacturing projects, driving 'right first time' start up and execution.
* Explore and understand technology and manufacturing challenges and synthesize business needs, manufacturing requirements, engineering elements, and technology inputs, etc. into business solutions.
* Clear technical reporting, ability to explain technical tradeoffs to non-technical stakeholders, strong negotiation and conflict resolution.
* High degree of collaboration with internal (manufacturing, quality, engineering) to develop standards and define project needs and priorities; as well as recruiting project team members.
* The incumbent must also have a thorough understanding of business requirements, effective communication skills, leadership, and interdependent partnering, conflict and risk management.
Qualifications
Education:
* Minimum of a Bachelor's or equivalent University Degree required; MS/MBA/Ph.D. PE Certificate preferred
Experience and Skills:
Required:
* A minimum of twelve (12) years of process engineering experience in GMP MFG facilities.
* Experience in green or brown field GMP MFG facility start-up including automation, utilities, facilities and operations.
* Strong technical background in Process engineering, strong analytical skills to synthesize business needs, manufacturing requirements, engineering elements, and technology inputs, etc. into business solutions Operational and financial fundamentals
* Familiarity with ASME BPE codes, PLC/DCS automation controlled systems, P&ID and clean utilities including: WFI, clean steam, plant steam, process gases, chemicals.
* The ability to lead and/or support multiple projects simultaneously
* Defines technical or scientific direction of programs composed of multiple complex projects
* Engineers new and modifies existing processes to ensure right first time process start up
* Track record of successful program execution and team outcomes
Preferred:
* FPX certification and Six Sigma and/or Lean experience are a plus
Other:
* This position is full time on-site role based in Wilson, NC
* This position may require up to 25% of domestic or international travel based on project business needs
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit *********************
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.
Required Skills:
Analytics, Automation, GMP Environments
Preferred Skills:
Agile Decision Making, Coaching, Consulting, Corrective and Preventive Action (CAPA), Crisis Management, Cross-Functional Collaboration, Disruptive Innovations, Emerging Technologies, Industrial Hygiene, Lean Supply Chain Management, Process Control, Process Engineering, Product Costing, Program Management, Project Schedule, Science, Technology, Engineering, and Math (STEM) Application, Tactical Planning, Technical Credibility, Technical Research
$100k-128k yearly est. Auto-Apply 2d ago
Implementation Manager
Johnson & Johnson 4.7
Raleigh, NC job
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
Job Function:
Project/Program Management Group
Job Sub Function:
Project/Program Management
Job Category:
Professional
All Job Posting Locations:
Dallas, Texas, United States, Fort Worth, Texas, United States, Horsham, Pennsylvania, United States of America, Orlando, Florida, United States of America, Phoenix, Arizona, United States, Pittsburgh, Pennsylvania, United States of America, Raleigh, North Carolina, United States
Job Description:
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at *******************/innovative-medicine
We are searching for the best talent for an Implementation Manager located in Pittsburgh, PA; Charlotte, NC; Raleigh, NC; Orlando, FL; Phoenix, AZ; or Dallas/Forth Worth, TX.
Purpose:
We are seeking an Implementation Manager to drive projects from initiation to completion. The Implementation Manager will own the launch process in designated therapeutic areas, defining project requirements and engaging with the main stakeholders to deliver projects to completion. The Manager will solve problems and advocate for solutions while securing stakeholder buy-in. Post-launch, the Implementation Manager will provide historical context to operational leadership and assist with change requests and program enhancements.
Responsibilities:
* Act as the primary point of contact for assigned implementations and own end-to-end delivery.
* Collaborate with key stakeholders to develop process flows, requirements and program solutions that enhance patient, provider and agent experiences.
* Ensure timely product development and implementation that meets PSC/PECS expectations.
* Collaborate with PSC technology group to review system requirements that enhance the agent experience.
* Facilitate conversations with operational teams to determine their needs and deliver solutions that optimize operational workflow.
* Define project scope and translate it into actionable tasks and schedules
* Manage implementation processes, including progress tracking, problem resolution, system implementation, testing, documentation, and training.
* Provide leadership to guide cross-functional teams toward project goals while maintaining quality and customer satisfaction.
* Lead cross-functional teams to effectively plan project meetings and drive accountability for deliverables.
* Update stakeholders on progress and manage expectations regarding project aspects.
* Identify issues, explore solutions and implement effective resolutions.
* Up to 25% travel is required.
* Perform additional duties assigned based on staffing and implementation needs.
Required Qualifications:
* Bachelor's Degree or higher.
* Minimum of 6 years' experience in HUB services implementation management, program management or operations management.
* Deep knowledge of patient support programs and patient access and affordability solutions (such as reimbursement services, free drug program and pharmacy services).
* Demonstrated ability to lead, manage and successfully launch new process or technology enhancements.
* Proven ability to lead and collaborate effectively with direct and indirect project teams.
* Ability to conceptualize, develop, implement and evaluate projects and processes.
Preferred Qualifications:
* Advanced Degree
* Program or clinical experience in the therapeutic areas of immunology and/or oncology
* Experience in medical benefits and infusion services
* Ability to proficiently use Microsoft Excel, Outlook, Word, and Visio
#LI-Remote
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills:
Agile Decision Making, Agility Jumps, Analytics Insights, Cross-Functional Collaboration, Expectation Management, Leadership, Organizational Project Management, Organizing, Process Improvements, Program Management, Project Management Methodology (PMM), Project Management Office (PMO), Project Management Tools, Project Reporting, Quality Assurance (QA), Statement of Work (SOW), Technical Credibility
$85k-108k yearly est. Auto-Apply 1d ago
MSAT Senior Scientist
Johnson & Johnson 4.7
Wilson, NC job
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
Job Function:
Supply Chain Engineering
Job Sub Function:
Process Engineering
Job Category:
Scientific/Technology
All Job Posting Locations:
Wilson, North Carolina, United States of America
Job Description:
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at *******************/innovative-medicine
Apply today for this exciting opportunity to be part of our growing team!
Manufacturing Science and Technology (MSAT) manages the process technology platform strategy to produce biotherapeutics in the new Bio-Processing Facility in Wilson, North Carolina. We are responsible for Process & Cleaning Validation, Standardization of Equipment for New Product Introduction, Process Analytics Introduction, and Life Cycle Management (LCM) of our commercial production processes.
In this critical role within the MSAT team, the downstream senior scientist will lead reduced scale model studies in the lab, as well as oversee large-scale studies at the manufacturing facility. This position will support commercial product introduction through technology transfer, assist process validation, and provide technical support for manufacturing investigations and health authority inspections.
Key Responsibilities:
* Support laboratories and production facility start up activities including the preparation of SOPs and working instructions, as well as coordinating laboratories instrument installation, commissioning and qualification.
* Lead the development of reduced scale chromatography and filtration model by generating protocols/reports, executing laboratory scale studies, and conducting scientific reviews of data to support commercial scale biotherapeutics drug substance cGMP manufacturing.
* Support technical transfer and validation activities through scientific review of proposed manufacturing processes, technical authoring of protocols/reports, execution of laboratory scale studies and collaboration with manufacturing operations.
* Support "process fit to plant" activities by offering valuable insights to both product life cycle management and manufacturing operations.
* Collaborate with the manufacturing department to support commercial manufacturing campaigns, including on-floor support.
* Provide technical support by leading / assisting manufacturing investigations as required, authoring / reviewing events, deviations and CAPAs, to help meet product release specifications and timelines.
* Participate in cross functional teams for the incorporation of process parameters into batch records and associated automation documents to ensure right-first-time process execution
* Collaborate with project teams to provide input, review and approval support for regulatory submissions.
* Interpret project plans and timelines for CMC projects, and schedule work and experiments to meet these goals.
* Lead training within the group on new processes, procedures, and use of equipment in the lab.
* Foster a culture of lean principles and continuous improvement within the department while promote collaboration with internal and external partners.
Qualifications
Education:
* A minimum Bachelors Degree in Biology, Pharmacy, Chemical Engineering, Bioprocess Engineering, or similar field required
Experience and Skills:
Required:
* B.S. with a minimum 6 years of relevant experience or Ph.D. /M.S. with a minimum of 3 year relevant experience
* Expertise in lab scale downstream process development
* Proven expertise in chromatography purification, viral filtration, ultrafiltration/diafiltration for monoclonal antibody process development or clinical / commercial manufacturing.
* Hands-on experience with laboratory scale chromatography purification system, with the ability to design and execute experiments or projects steps with minimum supervision.
* Experience within a regulated biologics or pharmaceutical industry.
* Solid understanding of process control strategy and implementation in the manufacturing environment.
* Excellent oral and written communication skills. Strong technical writing capability with keen attention to detail.
* Self-motivated with a dedication to staying up to date with regulatory and technical developments in the industry.
* Ability to work independently as well as in a cross-functional team environment, demonstrating strong collaboration skills and flexibility.
* Proven track record to adapt to rapid changes in project priorities and requirements.
* Advanced root cause problem solving with strong scientific data driven decision making ability.
Preferred:
* Knowledge of commercial scale equipment related to downstream production
* A minimum 3 years' experience within a regulated biologics or pharmaceutical industry.
* Experience in commercial scale disc stack centrifuge, transition analysis method for chromatography column qualification, and buffer in-line conditioning.
* Experience in the commercial biotherapeutics drug substance manufacturing process tech transfer.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit *********************
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills:
Agile Decision Making, Coaching, Corrective and Preventive Action (CAPA), Critical Thinking, Emerging Technologies, Issue Escalation, Lean Supply Chain Management, Problem Solving, Process Control, Process Engineering, Product Costing, Product Improvements, Science, Technology, Engineering, and Math (STEM) Application, Situational Awareness, Technical Research, Technologically Savvy, Validation Testing, Vendor Selection
$67k-94k yearly est. Auto-Apply 17h ago
Global EHS Manager
Danaher 4.6
Raleigh, NC job
Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Integrated DNA Technologies (IDT), one of Danaher's 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact.
You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life.
Our team at Integrated DNA Technologies (IDT), is united by a commitment to collaboration and scientific excellence, building on a strong foundation of innovation, expertise, and reliability. Guided by our vision to help researchers rapidly move from the lab to life-changing advances, we work closely with global partners to accelerate progress and genomics breakthroughs across fields like cancer, infectious disease, rare genetic disorders, and more. At IDT, you'll be part of a culture rooted in continuous learning and improvement-where your growth fuels our mission to accelerate the pace of genomics and helps shape a healthier, brighter future for all.
Learn about the Danaher Business System which makes everything possible.
The Global EHS Manager is responsible for driving adherence to standard work and ensuring consistent implementation of Environment, Health & Safety programs across global operations. This role delivers measurable impact by reducing incidents and improving compliance through leadership and operational excellence.
This position reports to the Director of EHS, is part of a multi-site and operating company Environment, Health & Safety Team and will be an on-site role at one of the IDT or Aldevron locations.
In this role, you will have the opportunity to:
* Drive adherence to standard work across global Environment, Health & Safety (EHS) programs to ensure consistent and effective safety practices.
* Implement and monitor compliance with EHS policies and procedures, maintaining high standards of safety and regulatory alignment.
* Lead global initiatives aimed at reducing incidents and improving overall safety performance throughout the organization.
* Collaborate with regional teams to ensure alignment with global EHS standards and facilitate the sharing of best practices.
* Provide leadership and guidance to EHS teams worldwide, supporting operational excellence and a proactive safety culture.
The essential requirements of the job include
* Bachelor's degree in Environmental Science, Occupational Health & Safety, Engineering, or related field
* 5+ years of proven leadership in environmental and safety compliance within a manufacturing environment, with a strong track record of driving result and experience in EHS management within global operations
* Proven expertise in implementing standard work and DBS methodologies
* Proficiency in EHS management systems and reporting tools and knowledge of global regulatory requirements and compliance frameworks
* Strong communicator, both written and verbal, and can lead training, investigations, and cross-functional collaboration with clarity and confidence.
* Able to lead, motivate, and partner with global and regional teams to elevate safety and environmental standards
Travel, Motor Vehicle Record & Physical/Environment Requirements: if applicable for role
* Ability to travel as required (up to 20%, including overnight stays)
It would be a plus if you also possess previous experience in:
* Professional certification in EHS or related discipline
* Experience with Danaher Business System (DBS) or similar continuous improvement frameworks
IDT, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.
The annual salary range for this role is 114,000 to 130,000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.
This job is also eligible for bonus/incentive pay.
We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.
Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit ****************
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.
The U.S. EEO posters are available here.
We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:************** or applyassistance@danaher.com.
$60k-71k yearly est. 24d ago
Senior Building Automation Engineer-BAS Lead
J&J Family of Companies 4.7
Wilson, NC job
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
**Job Function:**
Supply Chain Engineering
**Job Sub** **Function:**
Automation Engineering
**Job Category:**
Scientific/Technology
**All Job Posting Locations:**
Wilson, North Carolina, United States of America
**Job Description:**
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at *******************/innovative-medicine .
J&J is expanding our manufacturing capacity with $2 billion investment to support strong portfolio growth and continue delivering breakthrough innovation and transformational medicines for patients. The new facility will expand production of innovative biologic medicines in areas including oncology, immunology, and neuroscience. J&J's significant supply chain investment ensures a resilient and reliable future supply of medicines to meet accelerating demand for our current portfolio of medicines and our future innovations.
The GET (Global Engineering & Technology) organization operates as one integrated team in the delivery of Engineering, Maintenance and Execution Systems solutions. We operate in a standard, coordinated and consistent manner in support of the current and future requirements of our Manufacturing and Manufacturing Science and Technology (MSAT) and in partnership with key internal/external network.
Apply today for this great opportunity located in Wilson, NC!
The selected candidate will lead the delivery, support, and maintenance of site Building Automation System (BAS) and Utility Programmable Logic Controller (PLC) systems, including project execution, upgrades, system performance, vendor management, production and development systems, library standards and network infrastructure. After the go-live, this position will conduct the planning, design, scheduling, and control of automation projects to support new product development and base business.
**Key Responsibilities:**
+ Site primary contact for BAS and Utility PLC global standards supports and delivery.
+ Delivery and execution of the Site BAS and utility PLC Projects and strategies.
+ BAS and Utility PLC Technical Owner and SME for the site
+ Establishes methods for developing and gaining insight into system architecture to distill it into concrete design.
+ Assists in establishing and implementing automation requirements and is responsible for the scheduling, resource management, maintenance, and operational support.
+ Delivers technical reports, technical papers, and other documents.
+ Assists in the management of existing equipment and control systems in assigned areas and helps determine reliability and need for updates.
+ Conducts most complex assessments to determine regulatory compliance and any necessary improvements for regulation conformity.
+ Establishes automation, deliverables timelines and ensures adherence to expected deadlines.
+ Coaches more junior colleagues in techniques, processes, and responsibilities.
**Qualifications**
**Education:**
+ A Bachelor Degree in Engineering and/ or an Associates Degree with at least 8 years of experience in automation systems experience ; required
**Experience and Skills:**
**Required:**
+ A minimum of 6 years of experience in automation systems
+ Strong BAS (preferably in Honeywell BMS) and Siemens PLC experience.
+ In-depth Technical knowledge of BAS both hardware and software components
+ Experience within a pharmaceutical or GMP regulated manufacturing environment.
+ Project Management experience.
+ Good understanding of BAS system architecture and software design
+ Hands-on experience in managing automation vendors in larger projects
**Preferred:**
+ Key appreciation of Industrial Automation Networks and their Communication Protocols.
+ Process knowledge for HVAC, facilities, and utility systems.
+ In-depth understanding of the ISA S95 & S88 standards and how they should be used within the Global Supply Chain
+ Good appreciation of Industry 4.0/IIoT.
+ Solid understanding of the developing Digital World to transform Biopharma.
**Other:**
+ _Ability to travel up to 10% of the time, domestic and internationally_
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit ******************* .]
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers , internal employees contact AskGS to be directed to your accommodation.
**Required Skills:**
Automation, Engineering
**Preferred Skills:**
Automotive Supply Chain, Building Management System (BMS), Supply Chain, Systems Engineering
$88k-106k yearly est. 60d+ ago
QC Separations Specialist
J&J Family of Companies 4.7
Wilson, NC job
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
**Job Function:**
Quality
**Job Sub** **Function:**
Quality Control
**Job Category:**
Professional
**All Job Posting Locations:**
Wilson, North Carolina, United States of America
**Job Description:**
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at *******************/innovative-medicine
We are seeking an experienced **Separations Specialist** with expertise in **High-Performance Liquid Chromatography (HPLC)** to join our Quality Control (QC) team at a newly established large molecule manufacturing site in Wilson, NC. As one of the first fifteen employees in the QC department, you will play a foundational role in building laboratory capabilities, authoring procedures, and transferring analytical methods in a GMP-regulated environment.
J&J is expanding our manufacturing capacity with $2 billion investment to support strong portfolio growth and continue delivering breakthrough innovation and transformational medicines for patients. The new facility will expand production of innovative biologic medicines in areas including oncology, immunology, and neuroscience. J&J's significant supply chain investment ensures a resilient and reliable future supply of medicines to meet accelerating demand for our current portfolio of medicines and our future innovations.
**Key Responsibilities**
+ **Establish QC Capabilities:** Support the build-out of QC laboratory infrastructure and workflows for separations testing.
+ **Method Transfer & Validation:** Lead comparative testing and transfer of HPLC-based methods for biologics, ensuring compliance with global regulatory standards (FDA, EMA, ICH).
+ **Procedure Development:** Author, review, and approve SOPs, work instructions, and technical documentation for separations testing.
+ **Technical Expertise:** Serve as the subject matter expert for chromatographic techniques; train and mentor incoming QC personnel.
+ **Cross-Functional Collaboration:** Partner with MSAT, QA, and Operations to ensure seamless method implementation and resolve technical challenges.
+ **Compliance & Quality:** Maintain adherence to GMP, compendial requirements (USP, EP, JP), and site-specific quality standards. Support regulatory inspections and contribute to observation responses.
+ **Continuous Improvement:** Identify and implement process improvements to enhance efficiency and robustness of separations testing.
**Qualifications**
+ Bachelor's degree in Chemistry, Biochemistry, or related field; advanced degree preferred.
+ Minimum 6 years of experience in QC or analytical development within biologics or pharmaceutical manufacturing.
+ Strong expertise in HPLC and related separations techniques.
+ Proven experience in method validation, transfer, and regulatory compliance in a GMP environment.
+ Knowledge of compendial standards and global regulatory guidelines.
+ Excellent communication skills and ability to thrive in a dynamic, start-up environment.
**Key Competencies**
+ Entrepreneurial mindset with a passion for building new capabilities.
+ Detail-oriented and highly organized, with strong problem-solving skills.
+ Ability to work independently and collaboratively across functions.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (********************************) or contact AskGS to be directed to your accommodation resource.
**Required Skills:**
**Preferred Skills:**
$72k-88k yearly est. 13d ago
Senior Manager, Project Controls - Scheduling
J&J Family of Companies 4.7
Wilson, NC job
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
**Job Function:**
Project/Program Management Group
**Job Sub** **Function:**
Project/Program Management
**Job Category:**
Professional
**All Job Posting Locations:**
Wilson, North Carolina, United States of America
**Job Description:**
**About Innovative Medicine**
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at *******************/innovative-medicine
**We are searching for the best talent for** **Senior Manager, Project Controls - Scheduling to be located at Wilson, NC.**
At Engineering & Property Services (E&PS) we take care of all J&J buildings around the world providing end to end services from Real Estate, Engineering & Strategic Project Delivery to Facilities Management. We have a profound influence on the entire J&J Enterprise, providing innovative workplaces where our employees can collaborate and grow, and delivering flexible site solutions which enable our business to best serve our important customers and patients.
The Senior Manager, Project Controls - Scheduling role is responsible for compliant deployment of J&J Worldwide Procedures and E&PS Schedule Controls tools, guidelines and industry best practices throughout the lifecycle of the project. This candidate will require a strong background in collaborative planning, scheduling, cashflow management and risk management. This role will be part of the Americas Project Controls & Assurance team and a crucial part of strategic projects' onsite teams.
This role is responsible to drive standardization, through the ideation, definition, execution and assessment, and operational turnover project phases; including, but not limited to developing and managing detailed and cost-loaded schedules and value-focused metrics, progress reporting, and implementing and communicating risk management processes and best practices. In addition, this role will support the Project Leader to deliver on early end-to-end timelines, business case and execution approach alignment, project progress and reporting throughout the project phases, and lessons learned.
An ideal candidate for this role will have strong leadership experience with demonstrated competency interfacing with multiple levels of the organization including senior leaders (internally & externally); strong networking and relationship building skills; proven experience driving progress on large capital projects while remaining focused under ambiguous and complex situations.
Key relationships include collaborative working relationships with the J&J Project Delivery team, cross functional business teams, external partners, key stakeholders, and business leaders. This role will also ensure alignment with key E&PS functional partners (Global Finance, Project Management, CCFS and Facilities Management).
**You will be responsible for** **:**
+ Provide support to the Director, Project Controls - Site Lead on Front End Loading (FEL) / early end-to-end timeline efforts supporting the Capital investment by obtaining agreement on project definitions, scope, and priorities, and support the assessment of resources, capabilities, and project delivery processes.
+ Support the implementation of J&J's Project Delivery processes, particularly focusing on schedule and cashflow objectives, identifying and mitigating risk and adhering to key financial procedures.
+ Work with the project team to develop & align Capital Appropriation Request(s) detailed schedule and cashflow projections to ensure seamless progression of project approvals.
+ Ensure key tools and processes are in place to track project deliverables. Monitor and report on project progress to all stakeholders including status reports defining project risks and possible solutions. Ensure proper change control processes are in place and efficient.
+ Ensure that projects are implementing key Risk Management processes at all stages of project delivery (Cost & Schedule Risks assessments).
+ Attend meetings during the engineering, construction and commissioning/qualification phases.
+ Evaluate the Designer (AE), Construction Management (CM) and C&Q firm's performance with respect to schedule control, cashflow and change management.
+ Support project management in evaluating and analyzing time-impact and/or cashflow-impact change orders and forecasts.
+ Evaluate subcontract procurement plan, track performance against target dates.
+ Review schedules and cashflow projections for subcontracts prior to award, validate against project objectives.
+ Evaluate project time contingency and monitor usage throughout the duration of the project.
+ Review payment applications to validate progress claimed and ensure compliance with commercial/contract terms and project cashflow objectives.
+ Support maintenance and update of the 21-Tab / ESR to accurately:
+ Reflect status against the funding authorization and target schedule.
+ Identify key accomplishments, critical issues, and potential areas of concern.
+ Track project cashflow against plan.
+ Track project safety statistics.
+ Manage the overall schedule development, integration and management, including engineering and design deliverables, procurement tasks, and construction management tasks, integrated with IT-automation tasks, commissioning and qualification, operational readiness, process validation and technology transfer. This role will include hands-on schedule development and management, including cost-loading, updating, review, analysis and reporting to management, team leadership and team members.
+ Ensure proper schedule integration and focus on identification of critical and near-critical paths so that the project team can begin to consider possible mitigation plans in case of schedule delay.
+ Provide thorough review of the overall timeline and logic networks for all workstreams to ensure a true overall baseline.
+ Support teams in the development of programmatic/project-specific procurement strategies to meet timeline and cashflow objectives.
+ Identify areas of opportunities and risks while recommending courses of action that enable the project team to optimize its schedule performance.
**Qualifications / Requirements:**
**Education:**
+ B.S. in Business, Engineering, Architecture or Construction Management from an accredited institution is required.
+ Project Management Professional (PMP), PMI Scheduling Professional (PMI-SP), Planning & Scheduling Professional (PSP) or equivalent is required.
+ Proficient in Microsoft Excel, Project, PowerPoint, Power BI, Primavera P6 and/or Oracle Primavera Cloud, and Monte Carlo analysis is required.
**Experience, Skills & Knowledge:**
**Required:**
+ Minimum 10 years of project controls experience supporting major capital projects / relative business experience and project or operations management.
+ Extensive knowledge of engineering / construction / CQV / projects controls execution
+ Prior experience managing complex capital projects > $50MM in Supply Chain, R&D, Pharma or Medical Device.
+ Knowledge and experience of translating complex business needs into clear Final Project Objectives.
+ Track record of developing and maintaining highly collaborative partnerships at all levels within the organization.
+ Highly skilled listening and problem-solving skills when managing potential project conflicts.
+ Full working knowledge of Project Controls methodologies in schedule, cashflow forecasts development and risk control processes.
+ Familiarity with multiple contract types and implementation schemes.
+ Experience in integrated scheduling is required, working knowledge in collaborative Primavera platforms.
**Preferred:**
+ Familiarity with J&J Project Management approaches
+ Experience with web-based project management systems and Monte Carlo Cost analysis
+ Experience in an FDA regulated industry
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.
\#LI-Onsite
**Required Skills:**
**Preferred Skills:**
Agile Decision Making, Agility Jumps, Analytics Insights, Business Alignment, Continuous Improvement, Cross-Functional Collaboration, Leadership, Organizational Project Management, Organizing, Program Management, Project Management Methodology (PMM), Project Management Office (PMO), Project Management Tools, Project Reporting, Statement of Work (SOW), Technical Credibility
$103k-130k yearly est. 7d ago
Exp Eng Process Engineering ( 1 of 2)
Johnson & Johnson 4.7
Wilson, NC job
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
Job Function:
Supply Chain Engineering
Job Sub Function:
Process Engineering
Job Category:
Scientific/Technology
All Job Posting Locations:
Wilson, North Carolina, United States of America
:
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at *******************/innovative-medicine.
J&J is expanding our manufacturing capacity with $2 billion investment to support strong portfolio growth and continue delivering breakthrough innovation and transformational medicines for patients. The new facility will expand production of innovative biologic medicines in areas including oncology, immunology, and neuroscience. J&J's significant supply chain investment ensures a resilient and reliable future supply of medicines to meet accelerating demand for our current portfolio of medicines and our future innovations.
The GET (Global Engineering & Technology) organization operates as one integrated team in the delivery of Engineering, Maintenance and Execution Systems solutions. We operate in a standard, coordinated and consistent manner in support of the current and future requirements of our Manufacturing and Manufacturing Science and Technology (MSAT) and in partnership with key internal/external network.
Apply now for this exciting opportunity located in Wilson, NC !
Support the deployment of the MTO aspiration "to innovate to safely supply quality products and services competitively, faster, always". Responsible for providing engineering design and start-up of GMP large molecule biologics manufacturing facility systems, and equipment. Provide integrated equipment, utility, and facility engineering expertise with an operational focus in support of technology transfer and manufacturing projects to support 'right first time' execution and start up.
Drive innovative solutions in engineering support, and process technology. Coordinate with Technical Operations platform to ensure project alignment with technology standards and engineering specifications for manufacturing technology. This is intended to be a general job description and should not be construed as all-inclusive.
Key Responsibilities:
* Extensive interaction with external partners (A&E, construction firms, equipment vendors) to develop, organize and execute project plans as SME and process systems owner. The incumbent should demonstrate the following: detail and goal oriented, teamwork, customer-focus, thorough understanding of GMPs and regulatory requirements.
* Serve as Process Engineering Expert to develop business based technology solutions and provide integrated equipment, utility, and facility engineering expertise with an operational focus to support execution of strategic and key CAPEX manufacturing projects, driving 'right first time' start up and execution.
* Provide system ownership for bioprocess manufacturing equipment including review or URS, P&ID, C&Q, automation and architectural drawings and documentation.
* Explore and understand Technology and Manufacturing challenges and synthesize business needs, manufacturing requirements, engineering elements, and technology inputs, etc. into business solutions.
* Provide technical leadership of multi-functional teams on many projects/ process improvements and resolves inter-functional issues.
* High degree of collaboration with internal (manufacturing, quality, engineering) to develop standards and define project needs and priorities; as well as recruiting project team members.
* The incumbent must also have a thorough understanding of business requirements, effective communication skills, leadership, and interdependent partnering, conflict and risk management
Qualifications
Education:
* Minimum of a Bachelor's or equivalent University Degree in Chemical, Mechanical, Bioprocess Engineering or related field; required
* MS/MBA/Ph.D. PE Certificate preferred
Experience and Skills:
Required:
* Preferably 4+ years of process/plant engineering experience in GMP MFG large molecule biologics facilities.
* The ability to lead and/or support multiple projects simultaneously
* Track record of successful program execution and team outcomes
Preferred:
* FPX certification and Six Sigma and/or Lean experience are a plus
Other:
* Ability to travel up to 10%; international and domestic
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit *********************
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills:
Analytical Reasoning, Computerized Equipment Skills, Emerging Technologies, Gemba Kaizen, Issue Escalation, Lean Supply Chain Management, Problem Solving, Process Control, Process Engineering, Process Oriented, Product Improvements, Science, Technology, Engineering, and Math (STEM) Application, Situational Awareness, Supply Planning, Technical Research, Technologically Savvy, Validation Testing
$62k-78k yearly est. Auto-Apply 8d ago
Cloud Platform Engineering Architect (AWS)
Gilead Sciences 4.5
Raleigh, NC job
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Job Description
The Gilead Cloud Platform Engineering (CPE) Architect role will provide architectural leadership to the CPE DevOps Team on both delivery and support.
Description of Responsibilities
Gilead Cloud core platform services and automation development (design, development and delivery of technical code) for the AWS Control Tower Landing Zone
Terraform development impacting AWS account baselines, CI/CD integration with the platform, DMZ networking, and SCP management
Core platform and automation security hardening
Maintenance and support of core platform automation, guardrails and Security Control Policies (SCPs).
Platform development, coding, automation, role-based access control, authentication, Cyber Security hardening and cloud support
Continuous Integration/Continuous Delivery (CI/CD): Design, build, and maintain CI/CD DevSecOps pipelines to automate the building, testing, and deployment of applications. This includes Integration of CI/CD pipelines via automation with other services including security scanning, artifact repositories, ITSM, etc.
Infrastructure as Code (IaC): Manage and provision cloud infrastructure using tools such as Terraform to ensure consistent and repeatable deployments.
Cloud infrastructure management: Deploy, manage, and optimize cloud-based resources on platforms like AWS and Microsoft Azure.
Containerization and orchestration: Work with container technologies like Docker and orchestration systems like Kubernetes to manage and scale applications.
Monitoring and logging: Implement monitoring, logging, and alerting solutions to track application performance, system health, and security issues.
Security and compliance: Ensure that cloud environments and deployment practices adhere to security best practices and compliance standards.
Collaboration: Work closely with application teams, security, and quality assurance to troubleshoot issues and streamline processes.
Automation: Identify and automate manual and repetitive processes to increase efficiency and reduce human error. Leverage AI tools for improved automation and scale.
Troubleshooting: Perform root cause analysis and provide technical support to resolve issues in development, testing, and production environments.
Provide daily technical leadership and guidance to the Cloud Platform Engineering Core and CI/CD Engineering Scrum Team
Education and Experience Required:
Minimum Required Education and Years of Experience:
High School Degree and Fourteen Year's Experience
OR
Associates Degree and Twelve Years Experience
OR
Bachelor's Degree and Ten Years' Experience
OR
Masters' Degree and Eight Years' Experience
Public Cloud Services knowledge of AWS, MS Azure (a plus)
Development (coding) skills required, Terraform and GitHub expertise required
CI/CD DevSecOps opinioned pipelines subject matter expertise
Professional certifications a plus (Public Cloud, Architecture, Program Management etc.)
Agile/Scrum knowledge and leadership skills
Knowledge and Skills Required:
Subject matter expert on AWS, MS Azure Public Cloud services
Deep knowledge in Public Cloud Infrastructure and Application Architectures
Knowledgeable in all facets of compute, network and storage as it relates to Public Cloud Application Architecture
Subject matter expert in AWS Cloud Control Tower Landing Zone (CTLZ) architecture
Advanced knowledge of CI/CD DevSecOps opinioned pipelines and GitHub self-hosted runner architecture
Advanced code writing in multiple languages to design and deliver Gilead Cloud CI/CD pipeline services (primarily AWS, Azure a plus)
Code development in multiple languages preferred, expert skills in
Terraform and GitHub required
Understanding and capability to Lead an Agile Scrum Team
Strong root cause analysis skills to troubleshoot and resolve support escalations for Gilead Cloud core services
Develop and publish infrastructure and Application architecture designs
ITSM subject matter expertise to assist with implementation, integration, governance and improvement
Reporting and Analytics tools and development
Program Management skills - set up meetings, facilitate, assign actions, track/ follow up and report out
Proficient with Atlassian (Confluence and Jira), MS DevOps, MS Office, especially Outlook, Excel and PowerPoint. Use of large/complex Excel files will be required. GitHub expertise a must.
Advanced written and verbal communication skills
Specific job duties may vary and will flex to align with business requirements.
The salary range for this position is:
Raleigh: $168,980.00 - $218,680.00.
Bay Area: $195,670.00 - $253,220.00.
Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
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* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
For jobs in the United States:
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.