Test Engineering Manager (Contract Manufacturing)
San Francisco, CA jobs
Manufacturing Test Engineering Manager OR Lead
Direct Hire - 100% On-site in San Francisco, CA
Must Have - Contract Manufacturing AND Expert Level Python Automation
Preferred - Management experience
Red Oak Technologies is partnering with our client, a leader in LiDAR sensor technology, to identify a highly skilled Manufacturing Test Engineering Manager. We are open to considering strong Senior or Lead-level Test Engineers who are ready to take on team leadership responsibilities while continuing to code daily.
This role is fully onsite in San Francisco, CA.
Position Overview
The Manufacturing Test Engineering Manager will be a hands-on technical leader responsible for developing and maintaining production test software for high-volume LiDAR sensor manufacturing. The ideal candidate will have strong Python development skills, proven experience in test engineering for electro-mechanical assemblies, and the ability to mentor and guide a team while contributing individually on a daily basis.
The role requires close collaboration with cross-functional teams to improve test coverage, reduce test time, and ensure production readiness as new products move from development into manufacturing.
Key Responsibilities
Develop, maintain, and improve production test software using Python for LiDAR sensor and sub-assembly manufacturing.
Serve as a working manager, providing technical leadership while contributing hands-on daily.
Mentor and train Test Engineers on both technical and soft skills.
Establish team priorities, KPIs, and work goals aligned with product development schedules and company objectives.
Collaborate with cross-functional teams on software development, verification, and validation for new product introductions.
Drive continuous improvement initiatives, including test time reduction, data quality enhancements, and production process optimization.
Apply software engineering best practices, including coding standards, code reviews, source control management, CI/CD pipelines, and test automation.
Communicate project updates, risks, and recommendations to management and stakeholders.
Ensure timely completion of team deliverables and proactively address constraints or delays.
Support contract manufacturing facilities with occasional travel (less than 10%).
Work full-time onsite in San Francisco, CA.
Qualifications and Skills
Strong proficiency in Python development (minimum 5 years).
Experience with CI/CD infrastructure, GitLab, Jenkins, and SQL database design.
Strong skills in debugging, programming, data collection, and data analysis.
Experience using project tracking tools such as Jira, Confluence, or equivalents.
Proven ability to deliver results in a fast-paced engineering environment.
Excellent organizational skills with the ability to manage multiple concurrent projects.
Demonstrated people management or technical leadership experience (3+ years preferred).
Experience working with high-precision electro-mechanical assemblies.
Preferred: Experience developing test software for high-volume production and test equipment.
Education
BS in Computer Science, Mechatronics, Mechanical Engineering, or a related technical field required.
MS degree preferred.
Additional Information
Background screening is conducted by the client. The Manufacturing group has zero tolerance for misdemeanor or felony theft or robbery offenses.
This position is within an electrical component manufacturing environment (not medical devices).
About Red Oak Technologies
Since 1995, Red Oak Technologies has been a trusted partner in the technology industry, specializing in identifying and placing highly skilled contract, permanent, and project-based professionals. We value diversity and welcome applicants from all backgrounds and experiences.
Red Oak Core Values:
Relationships First | Exceptional Quality and Service | Unwavering Integrity and Trust | Be Easy To Do Business With | Respect Everyone
Job Type: Full-time
Work Location: In person
Group Lead Engineer - Data Security & Governance
Charlotte, NC jobs
Group Lead Engineer - Digital Data Compliance & Risk Job Details | Octapharma AG
Become part of a vital chain and contribute to our common goal of making people's lives better. Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing medicines sourced from human plasma and human cell lines. We are a privately-owned company, where the warmth of family meets the scale of a global organization.
Join us in shaping our vision to provide new health solutions advancing human life.
Your main tasks and responsibilities
As a Group Lead Engineer - Data Security & Governance, you will play a key role in ensuring Octapharma's data integrity, security, and compliance across all digital platforms. You will design and maintain data classification and protection strategies, developing frameworks that categorize data and digital records based on sensitivity and criticality. This includes implementing and enforcing policies for data handling, encryption, and access controls to ensure appropriate protection measures are applied at every level.
Your expertise will be instrumental in conducting comprehensive data risk assessments to identify vulnerabilities such as unauthorized access, data breaches, and data loss. You will develop mitigation strategies that uphold data integrity, confidentiality, and availability while ensuring operational efficiency.
In addition, you will oversee the entire digital records management lifecycle - from creation and storage to archiving and secure disposal - ensuring that all records are managed in compliance with internal policies and international standards. You will also ensure compliance and regulatory adherence, monitoring frameworks such as GDPR, HIPAA, and industry-specific standards to maintain Octapharma's commitment to responsible data management and legal conformity.
The ideal candidate has in-depth knowledge of Microsoft Purview compliance features, including Data Loss Prevention (DLP), eDiscovery, Insider Risk Management, and Information Governance. You will optimize compliance configurations, implement best practices, and support the organization in meeting regulatory and data protection requirements.
Your expertise and ideal skill set
Minimum of 7 years of experience in a related field, ideally within a manufacturing environment.
Solid understanding of risk management principles and methodologies.
Strong communication and leadership skills with the ability to translate complex technical topics into clear, non-technical language.
Proven ability to simplify regulatory and compliance requirements and work collaboratively across departments and sites.
Familiarity with control frameworks such as ISO 27001, CIS Controls, NIST, or IEC-62443.
Highly organized, self-motivated, and capable of managing multiple projects in a fast-paced environment.
Demonstrated discretion and professionalism when handling sensitive data.
Bachelor's degree in Engineering, Automation, Computer Science, or Management Information Systems (or a related field).
Technical risk management certification (e.g., Microsoft Certified: Information Protection and Compliance Administrator Associate) is a plus.
Microsoft Applied Skills in retention, eDiscovery, and Communication Compliance within Microsoft Purview are advantageous.
The Cyber Security team wish to welcome an aspiring candidate as part of our small team to make a positive impact on our expanded goals in Data and Digital Records.
- Richard Kearney, Group Director Information Security
Thrive with us
You help save lives - Every day is meaningful as we produce life-saving medicines
Family values - Long-term perspective for employees and relationships
Be rewarded with market-related salary and benefits package
You will have a high level of influence where you can make a difference and leave your footprint
Work with skilled and fun colleagues in a relatively informal organization
Skills development - We offer various internal and external employee and leadership trainings, trainee programs and digital solutions
It´s in our blood
We live diversity and stand for equal opportunities as an employer! We therefore look forward to receiving your application - regardless of age, gender, origin, sexual orientation, and religion. Please apply in English.
Manager - Engineering & Maintenance
Cranbury, NJ jobs
1. Equipment & Facility Maintenance
Lead maintenance of OSD manufacturing equipment such as blenders, granulators, fluid bed dryers, sifters, mills, tablet presses, capsule fillers, coating pans, dust collectors, compressors, chillers, boilers, AHUs, and dehumidifiers.
Implement robust Preventive Maintenance (PM) and predictive maintenance programs.
Conduct breakdown investigations and implement corrective actions.
Ensure critical facility systems (HVAC, electrical, plumbing, fire systems, BMS/EMS) are maintained and operate to required standards.
2. Regulatory Compliance & Documentation
Ensure compliance with FDA, cGMP, 21 CFR Part 11, OSHA, and related regulatory requirements.
Maintain records including PM logs, calibration reports, service documentation, change controls, deviations, and CAPAs.
Support internal and external audits (FDA, DEA, ISO, and customer audits).
3. Utilities & HVAC Systems Management
Manage key utilities such as compressed air, nitrogen, vacuum, HVAC, chilled water, steam, and RO/DI water systems.
Ensure qualified and compliant environmental controls for classified OSD manufacturing areas.
Maintain pressure cascades, temperature and humidity controls, and HEPA-filtered air systems.
4. Equipment Qualification & Validation
Work with Validation and QA teams on IQ/OQ/PQ protocols.
Manage requalification schedules and ensure equipment remains in a validated state.
Provide engineering assessments for change controls.
5. Safety, Risk Management & Compliance
Ensure adherence to OSHA, NFPA, and site safety requirements.
Implement safety programs including LOTO, confined space, hot work, and electrical safety.
Conduct incident investigations and lead corrective actions.
6. Spare Parts & Vendor Management
Maintain optimum inventory of critical spare parts.
Manage vendors, annual maintenance contracts (AMCs), and service agreements to control maintenance costs.
Evaluate and onboard modern technologies and suppliers.
Qualifications & Experience
Education:
Bachelor's degree in mechanical, Electrical, Chemical, or Industrial Engineering (or equivalent).
Preferred: Master's degree or certifications such as CMRP or PMP.
Experience:
8-15 years of engineering and maintenance experience in OSD pharmaceutical manufacturing.
Strong knowledge of manufacturing and packaging equipment, utilities, HVAC, and cleanroom systems.
Experience with FDA/DEA audits and equipment validation.
Must have a valid work permit.
Director - Engineering & Maintenance
Winslow, ME jobs
At Elanco (NYSE: ELAN) - it all starts with animals!
As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We're driven by our vision of ‘Food and Companionship Enriching Life' and our approach to sustainability - the Elanco Healthy Purpose™ - to advance the health of animals, people, the planet and our enterprise.
At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.
Making animals' lives better makes life better - join our team today!
Your Role: Director, Engineering & Maintenance
The Engineering Director oversees engineering and maintenance, ensuring cost-effective and timely services while managing the site's capital plan. This role supervises engineering and maintenance staff across various disciplines (process, automation, reliability, projects, facilities), focusing on staff productivity, development, and ensuring compliant equipment and systems for manufacturing. As a site lead team member, the Director collaborates across functions to support the technical agenda, business plan, strategic planning, and compliance objectives.
Your Responsibilities:
Safety and Leadership: Champion a safety-first culture and collaborate effectively with cross-functional teams (Operations, QA/QC, Regulatory, Supply Chain, Finance, HSE, etc.). Participate in leadership meetings, reviews, and business planning. Lead and support site and community engagement.
Personnel Management: Oversee engineering staff, including coaching, performance reviews, development plans, recruitment, resource allocation, and succession planning. Identify training needs and develop team skill sets. Support the security function of the site.
Financial and Performance Management: Monitor financial performance against targets. Track and report key performance indicators (KPIs). Drive continuous improvement and remove performance barriers. Oversee capital and maintenance budgets.
Compliance and Quality: Ensure adherence to regulations (including CFR 9 and USDA), Good Engineering Standards, Elanco Global Quality Standards, and other relevant corporate directives. Manage and develop reliability programs and equipment strategies to minimize downtime.
Facilities and Equipment Management: Oversee the Integrated Facilities Maintenance (IFM) provider, ensuring effective maintenance, cost-saving initiatives (energy/water conservation), and a safe, well-maintained facility. Manage projects on time and within budget.
What You Need to Succeed (minimum qualifications):
Bachelor's Degree in Engineering or related field.
Minimum 5 years' experience in a similar role.
Strong understanding of Commissioning and Qualification processes and ability to function in a team environment as a leader and as a member of the site leadership team.
What Will Give You the Competitive Edge (preferred qualifications):
Knowledge of freeze drier, fermentation, and fill line technologies.
Understanding of validation activities associated with vaccine process, technology transfer and process validation.
Exposure to Lean Six Sigma principles.
Experience with multiple Engineering Disciplines including Maintenance and Reliability, Capital Project Execution, Process Engineering and Process Automation (OT) in a regulated industry.
State of Maine Stationary Steam License (Minimum Fourth Class)
Additional Information:
Situations may arise where off-schedule work, both on-site and off-site, may be required.
Don't meet every single requirement?
Studies have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification. At Elanco, we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but
don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!
Elanco Benefits and Perks:
We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:
Multiple relocation packages for eligible roles
Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
8-week parental leave
9 Employee Resource Groups
Annual bonus offering
Up to 6% 401K matching
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
Auto-ApplyEngineering Manager - Database Administration
Pittsburgh, PA jobs
7,000 Diseases - 500 Treatments - 1 Rare Pharmacy
PANTHERx is the nation's largest rare disease pharmacy, and we put the patient experience at the top of everything that we do.
If you are looking for a career in the healthcare field that embraces authentic dedication to patient care, you don't need to look beyond PANTHERx. In every line of service, in every position and area of expertise, PANTHERx associates are driven to provide the highest quality outcomes for our patients.
We are seeking team members who:
Are inspired and compassionate problem solvers;
Produce high quality work;
Thrive in the excitement of the ever-challenging environment of modern medicine; and
Are committed to achieving superior health outcomes for people living with rare and devastating diseases.
At PANTHERx, we know our employees are the driving force in what we do. We cultivate talent and encourage growth within PANTHERx so that our associates can continue to explore their interests and expand their careers. Guided by our mission to provide uncompromising quality every day, we continue our strategic growth to further reach those affected by rare diseases.
Join the PANTHERx team, and define your own RxARE future in healthcare!
Location: Pittsburgh, PA (Hybrid)
Status: Full-Time
Reports to: Director, IT Infrastructure
Purpose
The Engineering Manager - Database Administration (DBA) will lead the development of a scalable, secure, and high-performing database environment. This role will begin as a 100% technical contributor and transition into a 50/50 split between hands-on engineering and team leadership. The Engineering Manager - Database Administration (DBA will architect and implement a comprehensive DBA strategy, collaborate with Analytics and Application teams, and build a resilient data infrastructure to support PANTHERx's rapid growth. As a Microsoft-centric organization with a majority of workloads on-premises, this role requires deep expertise in managing and optimizing on-prem database systems.
Responsibilities
Initial Phase (100% Hands-On)
Designs, implements, and maintains SQL Server and other on-premises database systems.
Develops and executes a Disaster Recovery (DR) and High Availability (HA) strategy.
Establishes change management, patching, and maintenance processes for all database systems.
Collaborates with the Enterprise Data Warehouse (EDW) and Analytics team (~25% of time).
Supports application teams with database deployments, performance tuning, and schema design.
Growth Phase (50% Hands-On / 50% Management)
Builds and leads a high-performing DBA teams to support the organization.
Defines and enforces database governance, security, and compliance standards.
Mentors junior DBAs and oversee workload distribution.
Partners with Infrastructure, Observability, and Software Development teams to ensure reliability and scalability.
Owns database-related incident response and conducting root cause analysis.
Required Qualifications
7+ years of hands-on DBA experience, including SQL Server and on-premises environments.
Proven experience designing and implementing DR/HA strategies.
Strong understanding of database performance tuning, indexing, and query optimization.
Experience working with data warehousing and analytics teams.
Familiarity with CI/CD pipelines and application deployment workflows.
Excellent communication and leadership skills.
Experience building or leading a DBA team is a plus.
Preferred Qualifications
PowerShell, T-SQL, or other scripting languages.
Experience with monitoring tools (e.g., Datadog, SolarWinds).
Knowledge of ITIL or formal change management frameworks.
Exposure to healthcare or regulated environments is a bonus.
Work Environment
This job operates in a home office and professional office environment. When in-office this role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines, and communications via MS Teams.
Physical Demands
While performing the duties of this job, the employee is regularly required to sit, see, talk or hear. The employee frequently is required to stand; walk; use hands and fingers to handle or feel; and reach with hands and arms. Visual acuity is necessary for tasks such as reading, observing surroundings, and working with various forms of data on a screen. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of the job.
Benefits:
Hybrid, remote and flexible on-site work schedules are available, based on the position. PANTHERx Rare Pharmacy also affords an excellent benefit package, including but not limited to medical, dental, vision, health savings and flexible spending accounts, 401K with employer matching, employer-paid life insurance and short/long term disability coverage, and an Employee Assistance Program! Generous paid time off is also available to all full-time employees, as well as limited paid time off for part-time employees. Of course we offer paid holidays too!
Equal Opportunity:
PANTHERx Rare Pharmacy is an equal opportunity employer, and does not discriminate in recruiting, hiring, promotions or any term or condition of employment based on race, age, religion, gender, ethnicity, sexual orientation, gender identity, disability, protected veteran's status, or any other characteristic protected by federal, state or local laws.
Auto-ApplyDirector, Engineering Assembly and Packaging Platform Technical Leadership
Pennsylvania jobs
Dir, Engineering - Director, Assembly and Packaging Platform Technical Leadership
Reporting into the Executive Director Packaging Technical Operations the Director Packaging and Assembly Platform Technical Leadership will be responsible and accountable for technical leadership, strategic planning and portfolio execution of key packaging and assembly platforms, with a focus on combination drug products such as prefilled syringes and autoinjectors.
The Packaging Technical Operations organization aims to be an industry leader in problem-solving, delivering robust and pragmatic technical solutions to accelerate the commercialization of new products, and ensuring an uninterrupted, compliant supply of commercialized products for the benefit of patients. The Director of Packaging and Assembly Platform Technical Leadership is integral to this mission. The successful candidate will possess deep technical expertise, a strong track record in problem-solving, strategic acumen, and execution, along with exceptional leadership skills to shape the technical capabilities and strategic direction for a global, cross-modality technical team.
The Director will lead a team of technical experts responsible for technical leadership of key packaging and assembly platforms. They will be responsible for executing the organization's priorities and ensuring the successful completion of projects. This includes the development and execution of robust technical plans across device assembly, packaging, and/or distribution and logistics of finished goods images, encompassing proactive risk management strategies, platform standards for standard finished goods images and packaging and assembly equipment standards, technical lifecycle management, and continuous improvement initiatives to guarantee the robustness and compliance of our company's product portfolio across the internal and external networks
The candidate is expected to build inclusive, collaborative partnerships with internal and external stakeholders, such as packaging and manufacturing sites, packaging & device development and technology teams, supply chain, operations, quality, analytical, regulatory, and project leaders. The successful candidate will demonstrate ownership and make informed cost/benefit decisions based on the analysis of inputs, outcomes, risks, and company-wide prioritization.
Essential Responsibilities:
Lead, mentor, and develop a team of technical staff, fostering a culture of continuous improvement.
Provide subject matter expertise and ensure scientific rigor, technical problem solving and execution excellence across the assembly and packaging platform portfolio, including interrogation of the data/ science through technical reviews and exploring alternative ways to view and solve problems to achieve results and ensure that all platforms (e.g. syringes, auto injectors, bottles, blisters) meet safety, efficacy, quality, and robust supply standards.
Drive proactive risk management activities, including risk assessment, risk mitigation, and risk communication strategies.
Develop and maintain strong relationships with internal stakeholders, including packaging commercialization, quality, analytical, regulatory, manufacturing, Device Development and Technology, Technical Product Leaders, and Value Chain to facilitate effective technical support and platform stewardship. This includes above site support for significant investigations, complaints monitoring and rapid response activities.
Develop and maintain key performance indicators (KPIs) to measure and improve the effectiveness of technical platform stewardship activities. Manage the total platform portfolio of work, holding the team accountable to deliver on priorities
Provide strategic leadership and direction for technical support for the platform stewardship team, including management of ongoing changes and tech transfers for the components, equipment, and processes. Deliver on the development, maintenance, and refinement of technical platform lifecycle management plans, setting and managing and optimizing platform standards.
Provide technical guidance to lifecycle changes for packaging platforms ensuring internal technical requirements are achieved and ensure filings with regulatory bodies to ensure compliance with relevant regulations and standards. Ensure thorough engineering, medical device and packaging science is applied to deliverables for new product introductions and tech transfers across the network inclusive of aligning the control and validation strategies.
Minimum Education Requirements and Experience:
Bachelor of Science (BS) in packaging/ mechanical/ chemical/ biochemical engineering, pharmaceutical science or chemistry or related fields with fifteen (15) years relevant experience pharmaceutical packaging, combination product assembly and packaging, or related technical fields; OR
Master of Science (MS) in packaging/ mechanical/ chemical/ biochemical engineering, pharmaceutical science or chemistry or related fields with twelve (12) years relevant experience pharmaceutical packaging, combination product assembly and packaging, or related technical fields; OR
PhD in packaging/ mechanical/ chemical/ biochemical engineering, pharmaceutical science or chemistry or related fields with eight (8) years relevant experience pharmaceutical packaging, combination product assembly and packaging, or related technical fields
Required Skills and Experience:
Subject matter expertise in medical device and combination product commercialization and tech transfer, assembly and packaging process improvement and support from early stage through launch and supply, including components, process, and equipment, as well as qualification and validation, medical device design controls and device risk management, and design verification/ validation.
Demonstrated experience in a leadership role; managing technical teams supporting packaging as well as combination product assembly & packaging.
Strong problem-solving and decision-making skills with an ability to determine interrogate the science, identify true requirements, and detect critical flaws including the ability to determine areas of potential risk, generate gap analysis and mitigation strategies
In-depth knowledge of global regulatory requirements for medical devices and combination products and packaging.
Strong understanding of risk management principles, including ISO 14971 and other relevant standards.
Strong strategic and analytical thinking, with a focus on driving continuous improvement and implementing best practices in technical support and product stewardship.
Excellent communication and interpersonal skills, with the ability to effectively engage with internal and external stakeholders.
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
The salary range for this role is
$153,800.00 - $242,200.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at *******************************************************
You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
Domestic
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Hybrid
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
n/a
Required Skills:
Applied Engineering, Applied Engineering, Change Management, Combination Products, Compliance Packaging, Continual Improvement Process, Cross-Cultural Awareness, Data-Driven Decision Making, Design Verification Testing, Driving Continuous Improvement, Engineering Standards, Key Performance Indicators (KPI), Leadership Project Management, Management Process, Manufacturing Scale-Up, Medical Devices, Medical Devices Design, Mentorship, Packaging, Packaging Engineering, Packaging Equipment, Pharmaceutical Packaging, Risk Assessments, Risk Communications, Social Collaboration {+ 3 more}
Preferred Skills:
Job Posting End Date:
10/11/2025
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Auto-ApplyManufacturing Engineering Manager
Sun Prairie, WI jobs
Pro-Active Engineering is a full-service electronic contract manufacturer dedicated to delivering high-quality, innovative solutions for our customers. For over 25 years, we have partnered with clients across industries to bring their products from concept to completion with speed, precision, and reliability. Our team is committed to continuous improvement, advanced manufacturing technologies, and a collaborative approach that ensures customer success. At Pro-Active Engineering, we take pride in our people, our processes, and our passion for engineering excellence. Join us and be part of a company that values innovation, teamwork, and professional growth. Role Overview: The Manufacturing Engineering Manager leads the Manufacturing Engineering function at Pro-Active Engineering, ensuring seamless integration of new and existing processes from notification of a purchase order to production. This role oversees the Manufacturing Engineering Technicians and Engineers, driving the creation and maintenance of manufacturing documentation, programs, tooling, and stencils. The manager ensures that processes are fully developed, validated, and ready within required timeframes to support efficient, high-quality production. Key Responsibilities:
Supervise and develop a team of technicians, including daily task assignment, training, coaching, and performance support.
Provide technical guidance and decision-making support to ensure customer requirements are met.
Collaborate with leadership to align manufacturing engineering strategies with overall company goals and customer expectations.
Lead, mentor, and develop team members while fostering collaboration and accountability.
Allocate resources and monitor workloads to meet timelines and production demands.
Establish, track, and report on KPIs related to readiness, process performance, and team effectiveness.
Oversee the development, release, and continuous improvement of manufacturing documentation and processes.
Partner with cross-functional teams to ensure smooth transitions from engineering to production.
Coordinate troubleshooting, root cause analysis, and corrective actions for production and process issues.
Monitor production schedules to confirm documentation, tooling, and programs are released and ready for production.
Ensure compliance with ISO Quality Management System requirements, company policies, and safety regulations.
Provide direct engineering and technical support, including failure analysis and hands-on production assistance when needed.
Competencies- The ideal candidate demonstrates:
Attention to detail, ensuring accuracy, quality, and compliance across processes and deliverables.
Team leadership, fostering collaboration, accountability, and respect while building a positive and high-performing work culture.
Technical expertise, applying tools, systems, and industry knowledge to guide teams in troubleshooting and delivering reliable solutions.
Problem-solving ability, identifying root causes, implementing practical solutions, and anticipating future challenges.
Critical thinking, analyzing complex information objectively, weighing alternatives, and making sound, evidence-based decisions.
Strategic mindset, aligning team goals with organizational objectives to drive operational excellence.
Coaching and development, mentoring team members to strengthen capabilities and prepare future leaders.
Work Environment & Schedule: While performing the duties of this role, the employee may occasionally work near moving mechanical equipment and be exposed to fumes or airborne particles. The work environment typically has a low to moderate noise level.
This position is based on-site at our Sun Prairie, WI facility.
Salary, full-time role with competitive pay.
Standard schedule is Monday through Friday.
Occasional weekend work as needed to support deadlines.
Requirements:
Bachelor's degree in STEM field and / or equivalent combination of education and experience / training required.
5+ years of experience in manufacturing engineering, with at least 2 years in a supervisory or leadership role.
Superior teamwork, multi-tasking, and time/project management skills.
Strong knowledge of PCB assembly, manufacturing processes, documentation, and quality standards.
Proven ability to lead technical teams, prioritize workloads, and deliver results under tight deadlines.
Excellent communication, leadership, and problem-solving skills.
Proficiency in relevant engineering software and ERP/MES systems.
ITAR REQUIREMENTS- To conform to U.S. Government export regulations, applicant must be a (i) U.S. citizen or national, (ii) U.S. lawful, permanent resident, (iii) Refugee under 8 U.S.C. § 1157, or (iv) Asylee under 8 U.S.C. § 1158, or be eligible to obtain the required authorizations from the U.S. Department of State.
Travel: Occasional travel may be expected for this position. Compensation and Benefits: Pro-Active Engineering offers a competitive wage based on experience and a generous benefits package to include health, dental, vision, life insurance, short and long-term disability, retirement plan with a company match, FSA, paid vacation, sick days, holidays and Gain Sharing bonuses. We also offer a business casual dress code. You can wear jeans every day!
Pro-Active Engineering is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or any other category protected by law.
Manufacturing Engineer/Operational Manager
North Carolina jobs
Contract furniture manufacturing employs LEAN Manufacturing practices to continuously improve the high mix, low volume nature of this business. Employee engagement is a pillar of our success, and the Engineering Manager is an integral part of this infrastructure. The role is multidisciplinary, requiring knowledge of people development and management, Process Design, Product Design, Quality Assurance, and Machine Maintenance activities within a manufacturing plant and across multiple internal and supply chain facilities.
This incumbent is responsible for supporting manufacturing on a day-to-day basis as well as maintaining surveillance over product design and manufacturing processes for the purpose of meeting the quality standard and controlling costs. A key requirement of this position is developing and implementing policies, standards and procedures for new and existing manufacturing methods.
The position is accountable for ensuring that the required level of service is provided in the area of manufacturing engineering to all areas of the manufacturing operation.
Accountable for leading a multi-disciplinary team to generate and implement cost reduction activities.
Lead and maintain a safety program with accountability shared by all employees.
Develop and implement plant wide LEAN manufacturing activities
Improve product quality using established Quality Control and Assurance methodologies.
Accountable for the maintenance of all process related machinery and equipment by ensuring a robust PM process is in place to support day to day operations.
Responsible for the management of the Maintenance Dept. and contractors conducting maintenance services
Responsible for leading plant Engineering Changes and develop plans to conduct any associated activities coming from such changes.
Review, approve and co-ordinate new launch information and activities as provided by design and the new products group. The manufacturing engineering manager must ensure that new launches are introduced as “production friendly” as possible. including, BOM's, routings and work cell designations, all must be reflected upon new products and during day-to-day manufacturing activities.
Accountable for reviewing product designs and making recommendations to ensure product costs and manufacturing targets are achieved. In addition, the position is responsible for determining methods, processes, equipment and technologies that enable StudioTK to cost effectively manufacture products.
Implementation and monitoring of Manufacturing Quality Assurance processes.
Maintain standards as stipulated in ISO 9001 (to be developed) & ISO 14000 where applicable to manufacturing engineering.
Determine the appropriate staffing requirements consistent with the department workload. In addition, this incumbent is responsible for directing the selection and training of personnel and overseeing performance management and pay program administration for his/her subordinates.
Together with Purchasing and Design Development Engineering, responsible for developing and working with NA & global suppliers to ensure required quality levels are achieved.
Maintain a highly motivated and enthusiastic workforce by working with the HR department in the development and implementation of programs that will attract, retain and motivate employees.
Ensure that training programs, whether internal or external be taken into account, and if deemed to be of benefit to both the employee and StudioTK, he/she will ensure that employees be provided with opportunity to attend, so as to improve individual skills, set productivity, technical competencies and provide career advancement/succession planning.
What is require for this role?
University degree in Mechanical or Industrial Engineering.
Minimum 10 years experience in a Manufacturing Environment.
Three or more years experience in a management position.
Good leadership/decision making skills.
Excellent Lean Manufacturing knowledge
Quality Assurance Methodologies
Working knowledge of powder painting, wood finishing, welding and automation.
Working knowledge of PFMEA, GD&T, GR&R, Control Plan development, PPAP submissions and APQP activities.
Working knowledge of AutoCad and Solidworks platforms
Experience in a durable goods, component assembly environment.
P.Eng, or eligible for P.Eng.
Excellent analytical and problem-solving skills.
Excellent time management skills and the ability to handle several tasks simultaneously.
Good interpersonal skills.
Ability to travel locally and internationally.
This Opportunity Offers
Competitive Salary
Excellent Health Benefits
401K
An exciting work environment
Studio TK is an equal opportunity employer and is committed to diversity and inclusion. We offer full time employment with competitive compensation and benefit packages including medical, dental, optical, and 401k.
Studio TK is committed to supporting a culture of diversity and accessibility across the organization. IT is our priority to remove barriers to provide equal access to employment. A Human Resources Representative will consult with applicants contacted to participate at any stage of the recruitment process.
Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
Auto-ApplyDirector, Data Engineering
Philadelphia, PA jobs
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Summary
As a hand-on leader & contributor to PCI Pharma Services' digital transformation, this role is responsible for leading the design, development and maintenance of robust data engineering solutions that enable real-time analytics, operational efficiency, and scalable innovation across the pharmaceutical product lifecycle. By building and optimizing data pipelines, platforms, and governance frameworks, this position supports PCI's mission to accelerate the delivery of life-changing therapies. The role aligns with PCI's commitment to excellence in clinical and commercial services, leveraging data as a strategic asset to enhance decision-making, ensure compliance, and drive continuous improvement across global operations.
Responsibilities:
Design, build, and maintain scalable, reliable and cost-efficient data pipelines to support analytics, machine learning, and operational use cases.
Lead data engineering initiatives that support AI/ML model development, deployment, and scalability across enterprise platforms in alignment with business priorities.
Manage and optimize data ingestion, transformation, and storage processes across structured and unstructured data sources ensuring high data availability and performance.
Administer and maintain data tools and platforms (e.g., Databricks, Airflow, dbt, Kafka) to ensure high availability and performance.
Collaborate with a data platform partner or vendor to implement, integrate, and evolve platform capabilities aligned with business needs.
Execute against the company's data strategy by translating strategic goals into technical roadmaps and deliverables.
Ensure data quality, integrity, and consistency through robust validation, monitoring, and alerting mechanisms.
Implement and enforce data governance, security, and compliance standards in collaboration with relevant stakeholders.
Work closely with data resources and business teams to understand data requirements and deliver fit-for-purpose solutions that meet defined SLAs.
Manage and mentor junior data resources and other technical resources, fostering a culture of learning, accountability and excellence.
Monitor and optimize data infrastructure costs, performance, and scalability in cloud and hybrid environments.
Develop and maintain documentation for data architecture, pipelines, and processes to support transparency and knowledge sharing.
Participate in code reviews, architecture discussions, and agile ceremonies to ensure high-quality engineering practices.
Evaluate and recommend new tools, frameworks, and technologies to improve the data engineering ecosystem.
Support incident response and troubleshooting for data-related issues, ensuring timely resolution and root cause analysis.
Work within approved CI/CD procedures to ensure consistent, secure, and automated deployment of data engineering solutions.
Drive automation and standardization across data workflows to improve efficiency and reduce manual effort.
Completes all job duties in compliance with company policy, SOP's, safety rules, along with all federal, state, and local regulations, including OSHA, FDA, cGMP standards and employment law.
This position may require overtime and/or weekend work.
Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
Attendance of work is an essential function of this position.
Performs other duties as assigned by Manager/Supervisor.
Required:
Experience with modern data platforms and tools (e.g., Databricks, Snowflake, BigQuery, dbt, Airflow, Spark).
Strong understanding of data modeling, ETL/ELT processes, and data warehousing best practices.
Familiarity with CI/CD tools and practices (e.g., GitHub Actions, Jenkins, Terraform).
Experience working in cloud environments (AWS or Azure).
Proficiency in SQL and at least one programming language (e.g., Python, Scala).
Bachelor's Degree in a related field and/or 5-7 years related experience and/or training.
College Level Mathematical Skills
Advanced Computer Skills: Ability to perform the most complex computer tasks and operate various computer programs.
Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables.
Preferred:
Experience working with data platform vendors or managed services.
Knowledge of data governance frameworks and compliance standards.
Exposure to data mesh or domain-oriented data architecture.
Experience mentoring or leading junior engineers.
Prior experience in a regulated environment, particularly in the pharmaceutical sector.
#LI-EK1
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future
Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
Auto-ApplyDirector, Business Development - Clinical Research
Secaucus, NJ jobs
Job Description
Director, Business Development - Clinical Research
Director, Clinical Business Development
Full Time
Remote-USA Based
Reports to: Senior Vice President, Clinical Services
Frontage Laboratories Inc.
Frontage Laboratories Inc. (Frontage) is a global contract research organization with broad expertise in supporting pre-clinical and clinical drug development. Frontage operates out of several different locations within the USA, Canada, and China. Frontage's core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, clinical research, and core laboratory services for clinical trials.
Frontage Clinical Services
At Frontage, we leverage more than 25 years of experience to develop a unique approach to overcome the challenges of every clinical study, while maximizing efficiency and mitigating risk. We apply best practices in study design and execution to advance each study to completion.
Responsibilities:
Secure and retain business through professional, consultative, and proactive sales activities directed at key decision makers
Strong negotiating skills, knowledge of legal contracts and experience with RFIs/RFPs and competitive bidding processes
Analyze potential opportunities and develop sales plans for each target account, develop in-depth knowledge of the customer organization
Ensure appropriate strategy/solution is proposed to clients
Monitor actions and results against plans
Lead client visits to the Frontage facilities
Coordinate with scientific and operations staff to prepare and lead the sales presentations, present comprehensive proposals, and lead follow-up activities
Monitor sponsor satisfaction by regular communication with the clients/sponsors
Record all client/sponsor sales related (opportunities, CDA, MSA, Site Visits, Face to Face Meetings, etc.) activities in CRM (sales
f
orce) system
Represent Frontage at trade shows and other meetings
Education, Skills and Experience Required:
BS degree or above, life science preferred.
3+ years' experience in a clinical operation role and /or 1+ years' experience selling early-stage clinical research services.
Solid understanding of the principles of drug discovery and development.
Knowledge and experience in DMPK & Safety Toxicology
Knowledge and understanding of FDA, GCP, and ICH regulations and guidance
Highly proficient in using Microsoft Office Suite: MS PowerPoint, MS Word, and MS Excel.
Attention to detail and ability to work simultaneously on multiple priorities. Able to adapt and be flexible to changing priorities.
Excellent oral and written communication skills.
Ability to travel.
Established industry client network is a plus.
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
Director, Business Development - Clinical Research
Secaucus, NJ jobs
Director, Clinical Business Development Full Time Remote-USA Based Reports to: Senior Vice President, Clinical Services Frontage Laboratories Inc. Frontage Laboratories Inc. (Frontage) is a global contract research organization with broad expertise in supporting pre-clinical and clinical drug development. Frontage operates out of several different locations within the USA, Canada, and China. Frontage's core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, clinical research, and core laboratory services for clinical trials.
Frontage Clinical Services
At Frontage, we leverage more than 25 years of experience to develop a unique approach to overcome the challenges of every clinical study, while maximizing efficiency and mitigating risk. We apply best practices in study design and execution to advance each study to completion.
Responsibilities:
* Secure and retain business through professional, consultative, and proactive sales activities directed at key decision makers
* Strong negotiating skills, knowledge of legal contracts and experience with RFIs/RFPs and competitive bidding processes
* Analyze potential opportunities and develop sales plans for each target account, develop in-depth knowledge of the customer organization
* Ensure appropriate strategy/solution is proposed to clients
* Monitor actions and results against plans
* Lead client visits to the Frontage facilities
* Coordinate with scientific and operations staff to prepare and lead the sales presentations, present comprehensive proposals, and lead follow-up activities
* Monitor sponsor satisfaction by regular communication with the clients/sponsors
* Record all client/sponsor sales related (opportunities, CDA, MSA, Site Visits, Face to Face Meetings, etc.) activities in CRM (salesforce) system
* Represent Frontage at trade shows and other meetings
Education, Skills and Experience Required:
* BS degree or above, life science preferred.
* 3+ years' experience in a clinical operation role and /or 1+ years' experience selling early-stage clinical research services.
* Solid understanding of the principles of drug discovery and development.
* Knowledge and experience in DMPK & Safety Toxicology
* Knowledge and understanding of FDA, GCP, and ICH regulations and guidance
* Highly proficient in using Microsoft Office Suite: MS PowerPoint, MS Word, and MS Excel.
* Attention to detail and ability to work simultaneously on multiple priorities. Able to adapt and be flexible to changing priorities.
* Excellent oral and written communication skills.
* Ability to travel.
* Established industry client network is a plus.
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
Director, Business Development - Clinical Research
Secaucus, NJ jobs
Director, Business Development - Clinical Research
Director, Clinical Business Development
Full Time
Remote-USA Based
Reports to: Senior Vice President, Clinical Services
Frontage Laboratories Inc.
Frontage Laboratories Inc. (Frontage) is a global contract research organization with broad expertise in supporting pre-clinical and clinical drug development. Frontage operates out of several different locations within the USA, Canada, and China. Frontage's core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, clinical research, and core laboratory services for clinical trials.
Frontage Clinical Services
At Frontage, we leverage more than 25 years of experience to develop a unique approach to overcome the challenges of every clinical study, while maximizing efficiency and mitigating risk. We apply best practices in study design and execution to advance each study to completion.
Responsibilities:
Secure and retain business through professional, consultative, and proactive sales activities directed at key decision makers
Strong negotiating skills, knowledge of legal contracts and experience with RFIs/RFPs and competitive bidding processes
Analyze potential opportunities and develop sales plans for each target account, develop in-depth knowledge of the customer organization
Ensure appropriate strategy/solution is proposed to clients
Monitor actions and results against plans
Lead client visits to the Frontage facilities
Coordinate with scientific and operations staff to prepare and lead the sales presentations, present comprehensive proposals, and lead follow-up activities
Monitor sponsor satisfaction by regular communication with the clients/sponsors
Record all client/sponsor sales related (opportunities, CDA, MSA, Site Visits, Face to Face Meetings, etc.) activities in CRM (sales
f
orce) system
Represent Frontage at trade shows and other meetings
Education, Skills and Experience Required:
BS degree or above, life science preferred.
3+ years' experience in a clinical operation role and /or 1+ years' experience selling early-stage clinical research services.
Solid understanding of the principles of drug discovery and development.
Knowledge and experience in DMPK & Safety Toxicology
Knowledge and understanding of FDA, GCP, and ICH regulations and guidance
Highly proficient in using Microsoft Office Suite: MS PowerPoint, MS Word, and MS Excel.
Attention to detail and ability to work simultaneously on multiple priorities. Able to adapt and be flexible to changing priorities.
Excellent oral and written communication skills.
Ability to travel.
Established industry client network is a plus.
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
Auto-ApplySenior Research Director, Analytical Chemistry - Synthetic Molecule Design and Development
Indianapolis, IN jobs
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
The Synthetic Molecule Design and Development (SMDD) organization is responsible for the development of synthetic drug substances and drug products from the pre-clinical phase through commercialization. Our scientists and engineers develop innovative technical solutions to advance an exciting portfolio that includes small molecules, synthetic peptides, oligonucleotides, and other emerging therapeutic modalities. By fostering a hardworking, culturally diverse workforce that exhibits deep technical expertise, SMDD delivers on these responsibilities and helps bring the next generation of life-changing medicines to patients.
Position Summary:
The Senior Research Director, Analytical Chemistry, will be responsible for the technical leadership and execution of analytical efforts for the commercial development of drug substance and/or drug product processes. Our team is seeking experienced, innovative, and motivated scientists to apply their strong foundation in analytical sciences and experience in synthetic process or formulated product development to enable clinical trials, regulatory submissions, and new product commercialization. This technical-track role offers the opportunity to lead the analytical effort within a multidisciplinary project team consisting of chemists, formulation scientists, and engineers while offering access to world-class capabilities for pharmaceutical development.
Responsibilities:
Drive implementation of technical solutions and analytical strategies to enable drug substance process or drug product formulation development.
Collaborate with project development teams, regulatory scientists, and manufacturing partners to deliver robust control strategies for drug substances, drug products, and/or drug product intermediates (e.g., spray-dried dispersions).
Apply prior experience authoring IND/CTA, NDA/MAA, and country-specific response to questions and/or registering products across global markets.
Provide technical guidance for analytical activities executed within the external network. Ensure methods are technically sound, well developed, and fit for purpose. Execute technology transfer to CRO/CMO organizations and Lilly manufacturing sites.
Demonstrate high learning agility and the ability to understand and exploit effective scientific concepts and methods across multiple subject areas (e.g., chemistry, pharmaceutical sciences, PAT, and modeling and simulation).
Mentor and develop scientific staff. Ensure continued technical and professional growth of group members, encourage efforts towards excellence and knowledge sharing.
Plan and manage short-term and long-term development activities. Develop and/or review technical agendas and timelines for project work. Recommend resource allocation to accomplish projects according to plans, communicate progress and propose changes in timeline, objectives, or direction.
Collaborate closely with organizations across development and manufacturing to deliver material and information for clinical trials and regulatory submissions.
Welcome varied perspectives to create new solutions.
Actively engage in the external environment; recognize and apply external innovation across the Lilly synthetic portfolio.
Basic Requirements:
Ph.D. in analytical chemistry or bioanalytical chemistry, or a related field
8+ years' experience in a pharmaceutical industry setting with specific focus on small molecules, synthetic peptides, or oligonucleotides.
Demonstrated expertise leading analytical efforts in pharmaceutical product development and commercialization. Proven skills developing, validating, and transferring analytical methods, authoring regulatory documentation, and overseeing CMO/CRO activities.
Must possess strong communication (oral, written), organizational, and leadership skills.
Additional Preferences:
Experience with product commercialization, including technical transfer of analytical methods into manufacturing operations.
Demonstrated ability to drive and accept change.
Good interpersonal skills and a sustained tendency for collaboration.
Demonstrated success in persuasion, influence, and negotiation.
Additional Information:
Travel: 0 to 10%
Position Location: On-site, Indianapolis, IN; Lilly Technology Center-North (LTC-N)
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$144,000 - $250,800
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
Auto-ApplyDirector, R&D Data Stewardship
King of Prussia, PA jobs
CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide.
We are looking for a Director R&D Data Stewardship to join the team.
**Main Responsibilities:**
+ Lead the implementation of data management frameworks, standards and best practices across selected R&D domains (e.g., Research, Clinical, Safety, Regulatory)
+ Coordinate with data owners, enterprise governance and Data Excellence/TES teams to ensure consistent data definitions, quality rules and metadata management.
+ Manage adoption of data standards, ontologies and controlled vocabularies across R&D data platforms & scientific systems.
+ Support integration of data management principles into data platforms and workflows in partnership with IT and platform teams.
+ Manage external stakeholders and partners to ensure data quality, compliance to standards, and adherence to contract & data-sharing agreements.
+ Monitor data stewardship KPIs and data quality metrics, lead remediation and optimization efforts.
+ Mentor data stewards and contribute to training and change management activities.
+ Promote data management as a foundational capability across the R&D organization.
**Skills & Qualifications:**
+ Bachelor's or Master's degree in Life Sciences, Information Science or related field.
+ 10+ years of experience in data stewardship, data governance or data management in Biomedical R&D.
+ Experience managing data across Research, Clinical, Safety, and/or Regulatory domains, with deep understanding of data standards, governance frameworks, compliance requirements, and cross-functional data integration.
+ knowledge of FAIR data principles and regulatory requirements.
+ Working knowledge of data governance tools (e.g., CENtree, Collibra, Informatica, Alation).
+ Experience with cloud data infrastructure and scientific data systems (ELN, CTMS, CDMS, Safety DB, RIM)
+ Strong stakeholder engagement and project leadership skills.
**About CSL Behring**
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit ******************** and CSL Plasma at ************************** .
**Our Benefits**
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL (********************careers/your-well-being) .
**You Belong at CSL**
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit ********************careers/inclusion-and-belonging
**Equal Opportunity Employer**
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit ********************accessibility-statement .
R-263347
CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status (specifically status as a disabled veteran, recently separated veteran, armed forces service medal veteran, or active duty wartime or campaign badge veteran) or other classification protected by applicable US federal, state or local law. CSL complies with all applicable employment laws, including but not limited to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act. ************************************************
Director, R&D Data Stewardship
Pennsylvania jobs
CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide.
We are looking for a Director R&D Data Stewardship to join the team.
Main Responsibilities:
Lead the implementation of data management frameworks, standards and best practices across selected R&D domains (e.g., Research, Clinical, Safety, Regulatory)
Coordinate with data owners, enterprise governance and Data Excellence/TES teams to ensure consistent data definitions, quality rules and metadata management.
Manage adoption of data standards, ontologies and controlled vocabularies across R&D data platforms & scientific systems.
Support integration of data management principles into data platforms and workflows in partnership with IT and platform teams.
Manage external stakeholders and partners to ensure data quality, compliance to standards, and adherence to contract & data-sharing agreements.
Monitor data stewardship KPIs and data quality metrics, lead remediation and optimization efforts.
Mentor data stewards and contribute to training and change management activities.
Promote data management as a foundational capability across the R&D organization.
Skills & Qualifications:
Bachelor's or Master's degree in Life Sciences, Information Science or related field.
10+ years of experience in data stewardship, data governance or data management in Biomedical R&D.
Experience managing data across Research, Clinical, Safety, and/or Regulatory domains, with deep understanding of data standards, governance frameworks, compliance requirements, and cross-functional data integration.
knowledge of FAIR data principles and regulatory requirements.
Working knowledge of data governance tools (e.g., CENtree, Collibra, Informatica, Alation).
Experience with cloud data infrastructure and scientific data systems (ELN, CTMS, CDMS, Safety DB, RIM)
Strong stakeholder engagement and project leadership skills.
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit ******************** and CSL Plasma at ***************************
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit ********************careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit ********************accessibility-statement.
Auto-ApplyManager, Facilities Engineering
Piscataway, NJ jobs
Facilities Engineering Manager is responsible to maintain the buildings and grounds of the organization, directing staff and overseeing the upkeep of equipment and supplies. The Facilities Engineering Manager will make sure the buildings and grounds are maintained, which entails daily and weekly cleaning schedules as well as determining and scheduling repairs, renovation projects, waste reduction improvements and safety inspections.The Facilities Engineering Manager is in charge of a budget and must negotiate with outside vendors for supplies, repairs and other measures.
Essential Functions:
Plans, directs and, through subordinates, supervises facility management services including building and facility operating systems maintenance, repair and improvement and custodial services; reviews and evaluates current operating procedures and personnel practices and establishes procedures, practice and priorities in keeping with effective operations and cost factors; coordinates building and maintenance activities within the division and with other divisions and departments to obtain optimum production and utilization of personnel and equipment.
Responsible for overseeing the following programs: validation, calibration, PM, BM, Purified Water, Pest Control, Environmental & Safety, parts procurement and management, permits maintenance, sanitization, engineering SOPs implementation and training.
Supervises trains and evaluates staff directly and through subordinate supervisors/lead workers; establishes and enforces operating and safety standards and procedures for maintenance services and repair; gives direction, resolves problems, prepares work schedules and sets deadlines to ensure completion of services.
Coordinates preparation of the division's budget; monitors budget expenditures; analyzes staffing and expenditures requests; reviews requests for additional services; prepares contract specifications and negotiates and administers service and construction agreements for maintenance and alteration services.
Plans and assigns activities with other divisions/departments in association with project construction and remodeling.
Conducts periodic inspections of facilities to review work in progress. Performs inspections of mechanical items, buildings, and HVAC systems. Monitors maintenance performance and standards, investigates unusual trends and recommends necessary adjustments.
Additional Responsibilities:
Responds to calls during emergency situations related to safety, production break-down or facility issues.
Reviews and recommends acceptance for equipment and supplies related to Building Facilities.
Conduct surveys to ensure compliance and recommend or take corrective action as required.
Maintains project files, databases, spreadsheets, related documentation and Log Books. Write comprehensive reports and memos.
Prepares/updates/approves engineering standard operating procedures.
Education:
Bachelors Degree (BA/BS) Manufacturing, Equipment and Facility Maintenance, Engineering, Electrical or related field - Required
Experience:
5 years or more in Manufacturing, Equipment and Facility Maintenance, Engineering, Electrical or related field with a GED.
3 years or more in Management of people or project experience
3 years or more in cGMP and Pharmaceuticals experience
Skills:
Team building, communication, writing, planning, leadership, supervising, decision-making, and goal-setting. - Intermediate
The salary for this position ranges from $130,000 to $140,000. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, as well as a long-term incentive award, such as restricted stock units, with this position within the first 12 months. Amneal ranges reflect the Company's good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life's many other commitments and opportunities.
Auto-ApplyManager, Facilities Engineering
Piscataway, NJ jobs
Facilities Engineering Manager is responsible to maintain the buildings and grounds of the organization, directing staff and overseeing the upkeep of equipment and supplies. The Facilities Engineering Manager will make sure the buildings and grounds are maintained, which entails daily and weekly cleaning schedules as well as determining and scheduling repairs, renovation projects, waste reduction improvements and safety inspections.The Facilities Engineering Manager is in charge of a budget and must negotiate with outside vendors for supplies, repairs and other measures.
Essential Functions:
* Plans, directs and, through subordinates, supervises facility management services including building and facility operating systems maintenance, repair and improvement and custodial services; reviews and evaluates current operating procedures and personnel practices and establishes procedures, practice and priorities in keeping with effective operations and cost factors; coordinates building and maintenance activities within the division and with other divisions and departments to obtain optimum production and utilization of personnel and equipment.
* Responsible for overseeing the following programs: validation, calibration, PM, BM, Purified Water, Pest Control, Environmental & Safety, parts procurement and management, permits maintenance, sanitization, engineering SOPs implementation and training.
* Supervises trains and evaluates staff directly and through subordinate supervisors/lead workers; establishes and enforces operating and safety standards and procedures for maintenance services and repair; gives direction, resolves problems, prepares work schedules and sets deadlines to ensure completion of services.
* Coordinates preparation of the division's budget; monitors budget expenditures; analyzes staffing and expenditures requests; reviews requests for additional services; prepares contract specifications and negotiates and administers service and construction agreements for maintenance and alteration services.
* Plans and assigns activities with other divisions/departments in association with project construction and remodeling.
* Conducts periodic inspections of facilities to review work in progress. Performs inspections of mechanical items, buildings, and HVAC systems. Monitors maintenance performance and standards, investigates unusual trends and recommends necessary adjustments.
Additional Responsibilities:
* Responds to calls during emergency situations related to safety, production break-down or facility issues.
* Reviews and recommends acceptance for equipment and supplies related to Building Facilities.
* Conduct surveys to ensure compliance and recommend or take corrective action as required.
* Maintains project files, databases, spreadsheets, related documentation and Log Books. Write comprehensive reports and memos.
* Prepares/updates/approves engineering standard operating procedures.
Auto-ApplyProject Manager, Engineering
Melrose Park, IL jobs
Job SummaryThe Engineering Project Manager leads and coordinates cross-functional projects to ensure delivery on time, within scope, and on budget. The role requires a balance of technical knowledge, structured project management, and leadership skills to plan, organize, and execute projects while maintaining clear communication with stakeholders.Responsibilities
Project Management
Plan, structure, and execute projects from initiation to completion, ensuring timelines, resources, and deliverables are aligned.
Apply project management methodologies to ensure effective execution and risk management.
Define clear project goals, milestones, and timelines, and implement structure from the start.
Technical Leadership
Leverage knowledge of product properties (aseptic, TS, bags, syringes, etc.), manufacturing technologies, and pharma execution strategies.
Support design reviews, qualification activities, and technical decision-making.
Drive structured problem solving and simplify complex challenges into actionable steps.
Business & Financial Management
Oversee project budgets, ensure cost control, and deliver within approved financial parameters.
Monitor and report on project performance to stakeholders, including senior leadership.
Team Leadership & Collaboration
Motivate, guide, and align cross-functional teams while managing conflicts and facilitating decision-making.
Communicate clearly and transparently with all stakeholders, including internal teams, customers, and senior leadership teams (SLT).
Ensure every voice is heard and considered in the decision-making process.
Continuous Improvement
Encourage team self-reflection and learning, fostering a culture of continuous improvement.
Identify and implement process enhancements to improve efficiency and effectiveness.
Travel
Expecting 20-30% travel based on projects
All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities.
Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
Auto-ApplyDirector RD&A
Beloit, WI jobs
Kerry is the world's leading taste and nutrition company for the food, beverage and pharmaceutical industries. Every day we partner with customers to create healthier, tastier and more sustainable products that are consumed by billions of people across the world. Our vision is to be our customers' most valued partner, creating a world of sustainable nutrition. A career with Kerry offers you an opportunity to shape the future of food while providing you opportunities to explore and grow in a truly global environment.
About the role
We are seeking a dynamic and experienced Director of R&D to lead our Stocks and Broths platform in North America. This role will drive innovation, technical leadership, and product development across customer segments including retail, QSR, foodservice, and industrial manufacturing. The Director will be responsible for shaping the future of authentic, clean label, and functional stocks and broths, partnering closely with cross-functional stakeholders to deliver value through science-backed, culinary-inspired solutions.
This is a high-impact leadership role that combines strategic thinking with hands-on technical expertise, offering the opportunity to directly influence product innovation for major North American food brands.
Key responsibilities
Strategic & Technical Leadership
- Lead the North America R&D strategy for the Stocks and Broths portfolio, aligning with regional commercial goals and global R&D platforms
- Identify and capitalize on growth opportunities by leveraging consumer trends, customer insights, and emerging technical capabilities
- Drive development of clean label, natural, and functional ingredient solutions with differentiated sensory and nutritional benefits
- Stay current with industry trends, competitive landscape, and regulatory changes affecting the stocks and broths category
Innovation & Product Development
- Lead product development across diverse platforms, including shelf-stable, refrigerated, and frozen formats
- Oversee end-to-end R&D processes from bench-scale research through pilot testing to full-scale production in Kerry and customer facilities
- Partner with process engineering, culinary, sensory, and regulatory teams to ensure technical feasibility, regulatory compliance, and consumer appeal
- Establish and maintain technical standards, protocols, and best practices for the stocks and broths platform
Customer Partnership & Business Development
- Act as a trusted technical advisor and innovation partner to key North American customers, providing deep expertise in culinary and savory solutions
- Lead technical discussions, co-creation sessions, and product presentations with customers
- Support business development efforts by translating customer needs into viable technical solutions
- Build and maintain strong relationships with customer R&D and procurement teams
Team Development & Cross-Functional Collaboration
- Manage, mentor, and develop a team of food scientists, technologists, and culinary developers across multiple locations
- Foster a high-performance, collaborative culture focused on scientific rigor, curiosity, and measurable business impact
- Work closely with commercial, operations, supply chain, quality, and regulatory teams to ensure seamless project execution
- Champion knowledge sharing and best practice development within the broader Kerry R&D organization
Qualifications and skills
Education & Experience
- Bachelor's degree in Food Science, Food Technology, Culinary Science, or related field; Master's or PhD strongly preferred
- 10+ years of progressive R&D experience in the food industry, with demonstrated expertise in savory systems, broths, stocks, or protein-based products
- 5+ years of leadership experience managing technical teams and complex projects
- Proven track record of leading product development projects from concept through successful commercialization
Technical Expertise
- Deep understanding of clean label formulation principles and natural processing technologies (hydrolysis, fermentation, extraction)
- Expertise in flavor chemistry, protein functionality, and thermal processing as applied to stocks and broths
- Knowledge of scale-up processes and manufacturing considerations for liquid food products
- Familiarity with U.S. regulatory standards (FDA, USDA) and customer quality requirements
Recommended salary range for this position is Minimum 177K/ Midpoint 244K/ Maximum 311K
Engineering Project Manager
Saint Louis, MO jobs
Candidate will be responsible for Multiple Automation Engineering Projects :
Manage design, installation, and quality testing aspects of automation projects in a GMP facility.
Understand and manage the Lifecycle of automation projects
Manage the materials planning, budget development, and cost control
Manage a detailed project schedule and work plan
Contribute to identifying and addressing complex technical issues
Interface with vendors, when necessary, to ensure vendors deliver parts, materials, components, equipment, and services on-time, on-budget, and to technical specifications
Requirements
Good technical understanding of the automation space.
Need technical knowledge of IT/automation (i.e. server upgrades, DeltaV, PLC ) and technical knowledge in the automation space is also necessary, but that's just to be effective as a PM.
A successful candidate for this position should possess technical knowledge including, but not limited to: data exchange, supervisory control (including SCADA systems and HMI's), historians, programming and configuration (specifically in control logic), distributed control systems (DeltaV) and integration with enterprise systems.