On-Site Paramedic - EMT-P - Sign-On Bonus Eligible
Biolife Plasma Services job in Kokomo, IN
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
$2500 Sign-On Bonus
Please take this virtual tour to get a sneak peek of one of our Plasma Donation Centers.
About BioLife Plasma Services
Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will report to the Plasma Center Manager and will perform as a Medical Support Specialist (Plasma Center Nurse) to support plasma center operations.
BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd.
About the role:
Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will determine donor eligibility to donate plasma, management of donor adverse events, review of laboratory test results, and donor notification of unsuitable test results. The Medical Support Specialist (Plasma Center Nurse) works under the guidance of the Center Manager (or Assistant Manager as applicable) for operational guidance and under the management of the Center Physician for medical issues. The Medical Support Specialist will be familiar with regulations of the plasma collection industry or a manufacturing environment. The Medical Support Specialist follows guidance provided by BioLife Medical Affairs and provides center level support of environmental, health and safety (EHS).
How you will contribute
You will determine donor eligibility; to include, proper management of informed consent, AIDS education and confidential self-exclusion, medical history interview and acceptance requirements, physical examination, blood testing, and reviewing Serological Protein Electrophoresis (SPE).
You will evaluate donor reaction(s), which occurs at the facility as outlined in the SOPs. Follow applicable SOPs for medical emergencies including the development of Center Physician's standing orders and donor transport to emergency care facilities.
You will refer to the Center Physician or Medical Affairs (as applicable) when in need of providing unacceptable findings to donors, or guidance concerning medical or technical issues, including donor safety and eligibility.
You will support the Hepatitis B and Seasonal Flu vaccination programs for employees as applicable.
You will manage employee incidents and determine whether further evaluation is required by occupational health/ER. Refer to EHS guidance regarding employee incidents.
You can be a Pandemic Coordinator when authorized by EHS and support investigations associated with pandemic threats within the local community as indicated by EHS or Medical Affairs.
What you bring to Takeda:
High school diploma or equivalent to including graduate equivalent of a recognized educational nursing program with state requirements
Currently licensed or certified in the state where responsibilities will be assigned: EMT-Paramedic
Current Cardiopulmonary Resuscitation (CPR) and AED certification
Fulfill state requirements (in state of licensure) for basic IV therapy
Satisfactorily complete the FDA approved training requirements for BioLife Medical Support Specialist
Two years in a clinical or hospital setting
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to bring Better Health and a Brighter Future to people around the world.
BioLife Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
USA - IN - Kokomo
U.S. Hourly Wage Range:
$23.85 - $32.79
The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsUSA - IN - KokomoWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Job Exempt
No
Auto-ApplyMedical Screener - Day One Benefits
Biolife Plasma Services job in Lafayette, LA
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.
**Job Description**
**Please take this** **virtual tour** **to get a sneak peek of one of our Plasma Donation Centers.**
About the role:
Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will report to the Plasma Center Manager and will perform as a plasma donor screener and perform phlebotomy to support plasma center operations.
How you will contribute:
· You will answer phones, and greet and focus on our donors, while ensuring the safety of donors and our team.
· You will screen new and repeat donors and take and record donor vital signs and finger stick results.
· You will use our Donor Information System, prepare donor charts, maintain accurate records, and coordinate donor compensation.
· You will help identify operational opportunities for continuous improvement and initiate changes to center processes using company approved procedures.
· You will be there for our donors, which includes working a variety of shifts, Saturdays and Sundays, and holidays.
What you bring to Takeda:
· High school diploma or equivalent
· Ability to walk and/or stand for the entire work shift
· Will work evenings, weekends, and holidays
· Ability to lean, bend, stoop, crouch, and reach above shoulders and below knees
· Ability to lift to 5 lbs., and occasional lifting of materials up to 32 lbs. and rarely 50 lbs.
· Fine motor coordination, depth perception, and ability to hear equipment from a distance
· Because of potential exposure to bloodborne pathogens (risk level 1), 90% of work tasks require prolonged glove wear
· 1 or more years minimum experience working in a customer or patient facing role is helpful
What Takeda can offer you:
Every day at Takeda, we feel good knowing that what we do helps improve the lives of patients with rare diseases. At BioLife, while you focus on our donors, we will support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program to include retirement benefits, medical/dental, family leave, disability insurance and more, all in a fast-paced, friendly environment.
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.
**BioLife Compensation and Benefits Summary**
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
**For Location:**
USA - LA - Lafayette
**U.S. Starting Hourly Wage:**
$16.00
The starting hourly wage reflects the actual starting rate for this position. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
**EEO Statement**
_Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law._
**Locations**
USA - LA - Lafayette
**Worker Type**
Employee
**Worker Sub-Type**
Regular
**Time Type**
Part time
**Job Exempt**
No
Senior Cost Controller (Utilities Construction)
Somerset, NJ job
At IPS, we are global leaders in developing innovative solutions for the consulting, architecture, engineering, project controls, procurement, construction management, and CQV of technically complex facilities, primarily in the life sciences industry. We are looking for a dedicated Senior Cost Controller, PJC, to join our talented team at our office located in Somerset, New Jersey.
In this role, you will be assigned to projects to review, coordinate, and summarize the activities of cost control, planning and scheduling, document control, and estimating.
Additional Responsibilities
Supervise the Project Control and Estimating personnel assigned to the project.
Identify and analyze potential project problems.
Recommend corrective action and follow up on recommendations.
Motivate subordinates to meet project objectives.
Promote communication and teamwork within the group and project.
Experience in developing and managing the following:
Project scheduling using the Critical Path Method (CPM)
Experienced in Earned Value Management (EVM)
Calculating Risk and Risk Management
Time Phased Cost Forecasting
Subcontractor Invoicing
Change Order management
RFP/Bid preparation and analysis
Produce the project cost and progress reports for the Project Manager and Client
Produce and maintain the Project Control Execution Plan.
Qualifications & Requirements
16+ years of professional experience.
Bachelor's degree in a technical field: engineering, project management, construction management.
Experience in developing and managing multiple concurrent projects and developing and executing PMO best practices.
Experience in all facets of Engineering, Procurement, and Construction Management (EPC).
High level of computer expertise in multiple industry-wide software products, such as:
MS Office Products
Scheduling software such as Primavera and MS Project
Client ERP systems such as JDE, QUAD, SAP, ARIBA, CONCUR
PPM Software: Prolog, Proliance, Prism G2, Procore, Cleopatra, Cora Systems
Context, Environment, & Safety
A safety-minded individual who must comply with the IPS Mission Zero Safety policy.
Capable of working alone or as part of a team without a significant level of supervision.
The employee is frequently required to stand, walk, and sit for long periods of time with extended computer use.
Experience working in both a Home Office and a Field environment.
Travel to client sites as needed.
This position is a safety-sensitive position. The employee is designated for field work and attends activities at client sites where they work in construction, process, packaging, manufacturing, research, or other "non-administrative" areas.
The salary offered for this role is between $100,000 and $140,000, but the actual salary offered is dependent on skills, experience, and education
All interviews are conducted either in person or virtually, with video required.
About Us
IPS, a Berkshire Hathaway company, is a global leader in technical consulting, architecture, engineering, procurement, construction management, commissioning, qualification, and validation services for technically complex facilities. Integration is how we think and work. It requires the ability to unite existing and emerging technologies into a process that reliably delivers products and accelerates speed to market. That end-to-end mindset allows us to be agile and anticipate challenges as we move projects toward operational readiness. IPS applies design and delivery expertise, client-side experience, and supplier-side insight to every project. We infuse our curiosity, our passion, and our commitment to partnership in delivering solutions at any scale. We meet our clients where they are and get them to where they need to go. That's only possible when we care as much as our clients do.
Specialties
Process Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV, and Staffing Services.
All qualified applicants will receive consideration for employment at IPS without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. IPS is proud to be an affirmative action and equal opportunity employer.
Connect With Us!
If you do not meet the qualifications for this specific role, but would like to submit your resume for general consideration, please click here!
Senior Plumbing and Fire Protection Engineer
Cary, NC job
At IPS, you will apply your knowledge, skills, and passion to make a difference in the lives of people, solving complex challenges related to pharmaceutical, biotech, and animal health research and manufacturing facilities. We are looking for a talented Senior Plumbing and Fire Protection Engineer to join our team at our office located in Cary, North Carolina.
In this role, you will work independently on various projects as assigned by a Project Manager or group leader. You will also play a role in the entire design process including but not limited to preliminary assessments, concept creation, design, problem resolution, and customer and vendor accessibility. Additionally, you may work on several concurrent projects and at times may assist as a technical expert on a specialized design.
What You'll Do
Assign and review the work of the project design team.
Check the progress of work and alert the Project Manager to changes in scope or additional services.
Attend pre-bid meetings and assist the project team in evaluating commercial proposals.
Assess the requirements of a project, break a project into tasks, and work with a Project Manager to determine the scope of work, budget, and staffing.
Write the scope of work for plumbing and fire protection designs based on preliminary reviews and meetings with the clients.
Develop design concepts and prepare documents during the design development phase.
Correct and update design documents.
Develops solutions to design problems.
Prepare engineering studies and schematic designs for new systems and analyze the operation of existing systems.
Use computer-aided design technologies to develop sketches, drawings, and construction documents.
Review drawings and documents to ensure compliance with company design and production standards.
Work with equipment suppliers/vendors to obtain the necessary information needed for design completion.
Interacts with clients regularly to secure scope and design intent.
Ensure acceptable levels of quality and check for coordination of work to ensure documents reflect design intent and necessary coordination.
Coordinate all aspects of project document completion within the company and externally with clients and other design professionals.
Coordinate design work with related engineering disciplines.
Attend job and construction meetings and participate in the coordination of the work.
Contribute to annual performance reviews for assigned staff.
Assist in the education and development of design staff and act as a resource for design questions.
Come join a caring, nimble team that delivers world-class designs for our pharmaceutical clients and take your career to new heights!
Qualifications & Requirements
8+ years of previous Plumbing and Fire Protection Engineering and Design experience.
Bachelor of Engineering Degree from an accredited University or relative trades experience
Registered Professional Engineer (PE).
Has previous experience working for an Architectural and Engineering firm (A&E).
Is proficient in the use of computers for design and understands CAD operations.
Has knowledge of all aspects of plumbing and fire protection systems; including Sanitary and Vent Systems, Storm Systems, Process Waste Systems, Lab and Vent Systems, Domestic Water Systems, Process and Lab Gas Systems, Sprinkler Design, and Wet/Dry/Pre Action Systems.
Is able to produce calculations for the above systems.
Has a demonstrated ability to manage projects, problem solve, and communicate effectively to all key personnel and time manage.
Able to travel up to 25%.
IPS will not sponsor employment visas for this position.
All interviews are conducted either in person or virtually, with video required.
About Us
IPS, a Berkshire Hathaway company, is a global leader in technical consulting, architecture, engineering, procurement, construction management, commissioning, qualification, and validation services for technically complex facilities. Integration is how we think and work. It requires the ability to unite existing and emerging technologies into a process that reliably delivers products and accelerates speed to market. That end-to-end mindset allows us to be agile and anticipate challenges as we move projects toward operational readiness. IPS applies design and delivery expertise, client-side experience, and supplier-side insight to every project. We infuse our curiosity, our passion, and our commitment to partnership in delivering solutions at any scale. We meet our clients where they are and get them to where they need to go. That's only possible when we care as much as our clients do.
Specialties
Process Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV, and Staffing Services.
All qualified applicants will receive consideration for employment at IPS without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. IPS is proud to be an affirmative action and equal opportunity employer.
Connect With Us!
If you do not meet the qualifications for this specific role, but would like to submit your resume for general consideration, please click here!
Vice President of Manufacturing
Portsmouth, NH job
The Alexander Technology Group is looking for a Vice President of Manufacturing
Full-time/perm
No 3rd party applicants will be considered
Key Responsibilities:
Must have experience scaling internal manufacturing for a medical device
Develop and execute the manufacturing, supply chain, and channel distribution strategy.
Serve as a key member of the executive leadership team contributing to company-wide strategic decisions.
Oversee the scale-up of internal manufacturing for new product launches, ensuring cost, quality, and timeline targets are met.
Implement lean manufacturing principles and continuous improvement initiatives.
Ensure compliance with medical device regulatory standards (e.g., FDA QSR, ISO 13485).
Develop a resilient and scalable supply chain strategy covering procurement, logistics, and inventory management.
Partner with commercial teams to ensure alignment between supply and market demand.
If interested, please send resume to ************************
CQV, Project Leader
Indianapolis, IN job
At IPS, you will apply your knowledge, skills, and passion to make a difference in the lives of people, solving complex challenges related to pharmaceutical, biotech, and animal health research and manufacturing facilities. We are looking for a CQV Project Leader to join our team out of our office located in ____________.
In this role, you will perform cGMP compliance-based services (commissioning, qualification, validation, consulting, etc.) as developed and defined in project agreements with IPS clients. Interfaces directly with IPS clients in the delivery of projects. May also manage and perform standalone commissioning services for non-FDA regulated clients.
Position Responsibilities
Assists an assigned Project Manager or is solely responsible for the successful delivery of compliance projects to IPS' clients.
Provides consistent, complete, and timely feedback and reports to IPS project managers or management of project status and issues.
Develops project schedules, deliverable tracking reports, scope adjustment notices, etc.
Supports, trains, and guides validation specialists/engineers in the delivery of C/Q/V services for assigned projects.
Writes and manages others in the preparation of C/Q/V documents following established standards and templates, including but not limited to the following:
C/Q/V Master Plans
Commissioning Forms
C/Q/V Protocols and Summary Reports
Standard Operating Procedures
Impact Assessments
Specifications (URS/FRS/DDS)
FATS/SATs
Manages others during field/site activities including, but not limited to, the following:
Attend and witness FATs and SATs as a representative of IPS clients
Execution of commissioning forms, witnessing of vendor start-up, and testing
Execution of C/Q/V protocols
Walkdown and verification of system drawings (P&IDs, as-builts, etc.)
Assists in deviation investigation and resolution of problems and issues encountered during field execution activities.
Coordinates with the Project Delivery department or CM for start-up and vendor testing.
Assists in proposal development including scope definition, attending bid meetings, development of hours and cost budgets, proposal presentations, etc.
C/Q/V of equipment and systems, including CSV and automation, supporting pharmaceutical, biotech, and medical device industries.
Come join a caring, nimble team that delivers world-class designs for our pharmaceutical clients and takes your career to new heights!
Qualifications & Requirements
A Bachelor of Science in Engineering is required for an Engineer; a Bachelor of Science in a related field is required for a Validation Specialist.
5+ years of experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation or QA.
Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms and protocols for GMP Utilities, Equipment, Systems, and Software.
Experience with Cleaning, Processes, Computer Systems, Methods, and other validation activities and processes is beneficial.
General exposure and experience in a GMP/Validation discipline with a knowledge and understanding of pharmaceutical.
Design/Build/Commission/Validation processes and how they relate to regulatory requirements and cGMP regulations within the E.U. and U.S. FDA.
Experience with a Risk-Based Approach to Commissioning and Qualification is beneficial.
Proficiency with Microsoft Office applications (Word, Excel, Project, PowerPoint, etc.).
Demonstrated knowledge of Project Management Principles.
All interviews are conducted either in person or virtually, with video required.
About Us
IPS, a Berkshire Hathaway company, is a global leader in technical consulting, architecture, engineering, procurement, construction management, commissioning, qualification, and validation services for technically complex facilities. Integration is how we think and work. It requires the ability to unite existing and emerging technologies into a process that reliably delivers products and accelerates speed to market. That end-to-end mindset allows us to be agile and anticipate challenges as we move projects toward operational readiness. IPS applies design and delivery expertise, client-side experience, and supplier-side insight to every project. We infuse our curiosity, our passion, and our commitment to partnership in delivering solutions at any scale. We meet our clients where they are and get them to where they need to go. That's only possible when we care as much as our clients do.
Specialties
Process Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV, and Staffing Services.
All qualified applicants will receive consideration for employment at IPS without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. IPS is proud to be an affirmative action and equal opportunity employer.
Connect With Us!
If you do not meet the qualifications for this specific role, but would like to submit your resume for general consideration, please click here!
Sales Development Representative
Bridgeport, MI job
Amigo Mobility International has been an innovation leader in motorized mobility and material handling solutions. We design and manufacture electric carts that help businesses improve safety, efficiency, and productivity. Our products are proudly built in the USA and trusted by some of the nation's largest retailers and distribution centers.
Amigo Mobility is seeking a motivated and detail-oriented Sales Development Representative (SDR) to help expand our reach within the Midwest material handling market. Working closely with our Account Executive, the SDR will focus on generating and qualifying new business opportunities through proactive outreach - including phone calls, emails, LinkedIn messaging, and other digital prospecting channels.
This is a desk-based role focused on developing new leads and converting them into qualified opportunities. The primary success metric will be scheduling product demos for the Account Executive.
Key Responsibilities:
Research, identify, and engage new business prospects within assigned industries and territories.
Conduct outbound prospecting via phone, email, and LinkedIn to introduce Amigo Mobility's products and solutions.
Qualify leads by understanding customer needs, challenges, and timelines.
Schedule product demonstrations for the Account Executive and ensure smooth handoff of qualified opportunities.
Maintain accurate records of activity, prospects, and pipeline in the CRM system.
Collaborate closely with marketing and sales teams to refine messaging and target lists.
Achieve weekly and monthly activity targets (calls, emails, demos scheduled).
Participate in ongoing product and sales training to strengthen knowledge of Amigo's solutions and value proposition.
Qualifications:
1-3 years of experience in inside sales, business development, or lead generation (B2B preferred).
Experience in material handling, industrial equipment, or capital equipment sales is a plus.
Proven success in prospecting and qualifying new opportunities.
Excellent verbal and written communication skills.
Strong organizational skills and ability to manage multiple leads and tasks simultaneously.
Comfortable using CRM systems and sales outreach tools.
Self-motivated, goal-oriented, and persistent in follow-up.
Compensation & Benefits:
Competitive base salary
Incentives for demos scheduled and additional bonuses when demos convert to sales
Health, dental, and vision insurance
401(k) with company match
Paid time off and holidays
Supportive, family-oriented company culture
Opportunity to grow into advanced sales or account management roles
Location:
Preferred: Based at Amigo Mobility's Bridgeport, MI headquarters
Remote: Candidates within the Midwest region will also be considered
If you're a motivated communicator who enjoys turning curiosity into conversations - and conversations into opportunities - we'd love to hear from you.
It is the policy of Amigo Mobility International, Inc. to provide equal employment opportunities to all qualified applicants without regard to race, color, age, religion, sex, national origin, disability or handicap, sexual orientation, gender identity or expression, height, weight, marital status, protected veteran status or as otherwise provided by law.
Pharmaceutical Development Scientist
Columbus, OH job
The Pharmaceutical Development Scientist is a hands-on technical role responsible for the formulation, development, optimization, and technology transfer of sterile and non-sterile drug products across STAQ Pharma's 503B Outsourcing Facilities. Reporting directly to the Chief Pharmaceutical Officer, this position supports product development initiatives from concept through scale-up and commercialization, driving innovation, process improvement, and lifecycle management of compounded drug products.
The scientist collaborates closely with Manufacturing Sciences & Technology (MS&T), Quality, and Production teams to translate laboratory-scale formulations into scalable, validated CGMP manufacturing processes. Responsibilities include conducting pre-formulation and compatibility studies, preparing R&D and pilot-scale batches, and analyzing analytical and stability data to identify optimal formulations that maximize quality, performance, and product expiration dating.
This role requires strong analytical chemistry expertise-including the ability to interpret UPLC chromatograms, assess impurity profiles, and apply ICH and FDA 503B guidance-to guide formulation strategy, product development, and technology transfer activities.
Key Responsibilities:
Develop, optimize, and scale formulations for sterile and non-sterile dosage forms in compliance with CGMP, FDA 503B, and ICH guidelines.
Conduct pre-formulation studies, excipient compatibility testing, and stability evaluations to inform formulation design and shelf-life optimization.
Design and execute experiments to assess formulation feasibility, process robustness, and long-term product stability.
Prepare and manufacture laboratory-scale, R&D, and pilot-scale batches for testing and process development.
Lead and support technology transfer activities for new and existing products, ensuring seamless transition from R&D to manufacturing and between STAQ Pharma sites.
Conduct literature reviews and data analysis to identify innovative formulation approaches and support development strategy.
Analyze data from HPLC, GC, dissolution, and stability studies to assess potency, purity, and impurity profiles.
Collaborate with MS&T, Quality, and Production teams to ensure manufacturing processes are robust, validated, and scalable.
Develop and execute stability protocols, trend data, and prepare detailed technical summaries and reports.
Write and maintain technical documentation, including batch records, development protocols, SOPs, and technical reports in accordance with CGMP standards.
Support investigations of out-of-specification (OOS) or out-of-trend (OOT) results and contribute to CAPA development and implementation.
Participate in audits, inspections, and internal quality reviews to ensure regulatory and operational compliance.
Qualifications:
Bachelor's, Master's, or Ph.D. in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related discipline.
Minimum of 3-5 years of hands-on experience in CGMP pharmaceutical formulation or product development (503B, CDMO, or sterile pharma manufacturing preferred).
Demonstrated experience in formulation design, stability testing, and technology transfer.
Proficiency in analytical chemistry techniques, including UPLC, GC, and dissolution testing; ability to interpret chromatograms and impurity profiles.
Strong working knowledge of ICH Q8-Q10, FDA 503B guidance, and applicable USP chapters.
Experience in scale-up and process optimization for aseptic and non-sterile drug products.
Excellent technical writing, communication, and organizational skills.
Ability to work independently, prioritize multiple projects, and collaborate effectively across cross-functional teams and sites.
Licensed Practical Nurse (LPN)
Minoa, NY job
$5,000 Sign on Bonus!!!
LPN-Licensed Practical Nurse
Onondaga Center for Rehabilitation & Healthcare is actively hiring LPN Team Members for our skilled nursing facility.
Base rate $28.33-$31.90 with an additional $0.75 shift differential for evening and nights!
Full time and part-time positions available!
Onondaga Center offers the following benefits:
Tuition Reimbursement Program!
Generous pay rates based on experience
Extra evening and night shift differentials
Flexible schedules for Full-Time or Part-Time status
Career Advancement Opportunities
Education Discounts
Two-Tiered Insurance Plan: Medical and Dental included!
DUTIES
Collecting required information from new Residents to be admitted.
Recording health details of Residents; including vitals & temperature.
Administering medications and injections to Residents as needed.
Treating and dressing wounds and bedsores as needed.
May be required to supervise Certified Nursing Assistants (CNAs).
Helps Residents get dressed & take care of personal hygiene.
Monitors Residents' food and liquid intake and output.
REQUIREMENTS:
Must be able to work as a team member.
Valid NY State LPN license.
Must be in good standing with State Registry.
LOCATION:
Minoa, NY
ABOUT US:
Onondaga Center for Rehabilitation and Nursing is an 82-bed rehabilitation and skilled nursing facility located in a residential neighborhood in the picturesque village of Minoa, New York. We pledge to be innovative in our processes and procedures and to continually set the standard of excellence among skilled nursing facilities, where residents find their physical, social and spiritual needs met by caring, compassionate people. Staying active, engaging with neighbors and visitors, and keeping fit are all part of the day at Onondaga Center. Onondaga Center is a proud member of the Centers Health Care Consortium.
Electrical Commissioning Lead- Mission Critical Facilities
Germantown, MD job
At IPS, we are global leaders in developing innovative solutions for the consulting, architecture, engineering, project controls, procurement, construction management, and CQV of technically complex facilities, primarily in the life sciences industry. We are looking for a talented Electrical Commissioning Lead - Mission Critical Facilities to join our dedicated team at our office located in Cary, North Carolina.
In this role, you will perform mission-critical & high-tech facilities commissioning-based services with a primary focus on standalone commissioning. You will also consult on and manage commissioning projects as developed and defined in project agreements with IPS' clients. Additionally, you will perform site auditing, quality reviews, and commissioning services as required to meet project requirements.
Additional Responsibilities
Demonstrated/recognized areas of expertise by industry in start-up, QA/QC, and commissioning.
Provide working knowledge in the delivery of technical projects in these areas.
Provide consulting-based services in areas of expertise.
Manages/leads project teams delivering primarily standalone commissioning.
Equipment pre-start-up and start-up procedures; Development of test scripts, checklists, and Comprehensive Commissioning documentation.
Oversee complete commissioning and performance acceptance testing of the electrical infrastructure systems, as well as other systems.
Development of electrical equipment and system functional test procedures.
Provide test and documentation that the equipment is delivered, installed, and tested correctly and set to function properly for the customer.
Review design criteria, specifications, drawings, equipment submittals, and other documentation pertinent to commissioning.
Integrated system testing; Compilation of all testing procedure results.
Commission plan preparation; Follow company QC process and procedures.
Support, train, mentor, and guide Commissioning Consultants and overall department staff in the delivery of commissioning services and areas of expertise.
Perform commissioning-related audits of clients' facilities and quality systems.
Assumes Project Management/Project Executive roles as requested and required to meet IPS workload demands.
Remains highly active in professional organizations and strives to be recognized in the industry.
Provides training and seminar presentations to industry.
Networks at professional functions and develops project leads and opportunities through industry contacts.
Supports strategic BD activities through networking.
Generates and performs commissioning deliverable activities, audits, and other related services as required, to meet project requirements and personal billability goals.
Works with potential new and existing clients to initiate projects following current industry practices.
Performs strategic and master planning activities to assure projects are initiated/started “on the right foot”.
Other duties as assigned.
Qualifications & Requirements
A Bachelor of Science in Engineering or a Bachelor of Science in a related field is required or equivalent experience.
8+ years' experience in the Electrical Field.
Has demonstrated/recognized areas of expertise by industry in start-up, QA/QC, and commissioning.
Experience with commissioning and other related activities and processes.
Knowledge of OSHA and NFPA 70E safety requirements.
Detailed experience in a commissioning discipline with a knowledge and understanding of mission-critical.
Design/Build/Commission/ processes.
Familiar with LEED commissioning requirements.
Knowledge and commissioning experience with Electrical Distribution Switchgear, Substations, Uninterruptible Power Sources (UPS), Automatic Transfer Switches (ATS), Batteries, Emergency Diesel Generators & Load Banks.
Preferred Qualifications
A/E experience working in complex High-Tech facilities or mission-critical projects.
Physical Demands
Must be able to stand, sit, and walk for prolonged periods.
Must possess the ability to stoop, kneel, crouch, and crawl as required.
Must be able to lift and move objects weighing up to 25 pounds.
Must be able to climb ladders as necessary.
Work Environment
Must be able to work in both indoor and outdoor environments, which may include exposure to varying working conditions.
Travel
This position will have up to 100% travel, or as required by the assigned project.
Position may be assigned to a client site for an extended period.
Overnight travel or staying in the city of the Client's location is possible, depending on the assignment.
Travel will be per the IPS Travel Policy, client-specific travel policy, or project-specific travel plan.
Must have access to reliable transportation.
Safety
This position is a safety-sensitive position.
The employee is designated for field work and attends activities at client sites where they work in construction, process, packaging, manufacturing, research, or other "non-administrative" areas.
The salary range for this role is $153,200 to $203,050, depending on experience and skills.
All interviews are conducted either in person or virtually, with video required.
About Us
IPS, a Berkshire Hathaway company, is a global leader in technical consulting, architecture, engineering, procurement, construction management, commissioning, qualification, and validation services for technically complex facilities. Integration is how we think and work. It requires the ability to unite existing and emerging technologies into a process that reliably delivers products and accelerates speed to market. That end-to-end mindset allows us to be agile and anticipate challenges as we move projects toward operational readiness. IPS applies design and delivery expertise, client-side experience, and supplier-side insight to every project. We infuse our curiosity, our passion, and our commitment to partnership in delivering solutions at any scale. We meet our clients where they are and get them to where they need to go. That's only possible when we care as much as our clients do.
Specialties
Process Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV, and Staffing Services.
All qualified applicants will receive consideration for employment at IPS without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. IPS is proud to be an affirmative action and equal opportunity employer.
Connect With Us!
If you do not meet the qualifications for this specific role, but would like to submit your resume for general consideration, please click here!
Project Manager (Utilities Construction)
Somerset, NJ job
At IPS, we are global leaders in developing innovative solutions for the consulting, architecture, engineering, project controls, procurement, construction management, and CQV of technically complex facilities, primarily in the life sciences industry. We are looking for a dedicated Project Manager to join our talented team at our office located in Somerset, New Jersey.
In this role, you will manage project coordination with Inside Plant (“IP”) Construction and Outage Planning, the engagement of various internal departments in the project, and communicate directly to ensure that project support needs are met by internal departments. You will also manage Project Engineering in the development of the Material Tracking Log (“MTL”), support all material procurement activities, and ensure that the MTL is maintained throughout the Project lifecycle.
Additional Responsibilities
Organizes weekly engineering meetings between Project Management, Project Engineering, Project Controls, Procurement, Licensing and Permitting, Corporate Properties, and the Architectural Engineering (“A&E”) firms.
Ensures the creation and distribution of weekly action item lists to project stakeholders.
Coordinates daily communication between the Project management team, Project Engineering, and the A&E firms.
Creation and management of the Project Scope Document, and participation in the procurement of all stakeholder signatures.
Creation and management of the Project Execution Plan and Risk Register, and participation in the stakeholder approval process.
Review Contractor submittals, including monthly reports, schedules, and cash flow documents.
Manage the following:
facilitation of design reviews by the Project Engineering Division, and ensuring that everything is signed by the appropriate parties
the development of monthly reports for the project and engaging all stakeholders in contributing to their individual sections
the facilitation of project detailed design by the A&E firm, and support the preparation, development, and review of technical specifications
the execution of the Quality Assurance and Control Plan
Project closeout activities, including lessons learned meetings, the submittal of As-Built drawings, documentation turnover, and the closeout of all permits and purchase orders.
Support site construction management in verifying that construction activities comply with design and specifications, and support the execution of the detailed commissioning and testing plan.
Support the documentation of all lessons learned activities in the Company database.
The salary range for this role is between $120,000 and $150,000 but actual salary offered is dependent on experience, skill set and education.
Qualifications & Requirements
15+ years of professional experience.
Bachelor's degree in a technical field: engineering, project management, construction management.
Professional credentialing is strongly encouraged (CCT or CCP, CST or CSP, EVP, CMIT or CCM, EIT).
PMP Certification.
High level of computer expertise in multiple industry-wide software products, such as:
MS Office Products
Scheduling software such as Primavera and MS Project
Client ERP systems such as JDE, QUAD, SAP, ARIBA, CONCUR
PPM Software: Prolog, Proliance, Prism G2, Procore, Cleopatra, Cora Systems
Context, Environment, & Safety
A safety-minded individual who complies with the IPS Mission Zero Safety policy.
Capable of working alone or as part of a team without a significant level of supervision.
The employee is frequently required to stand, walk, and sit for long periods of time with extended computer use.
Experience working in both a Home Office and a Field environment.
Travel to client sites as needed.
This position is a safety-sensitive position. The employee is designated for field work and attends activities at client sites where they work in construction, process, packaging, manufacturing, research, or other "non-administrative" areas.
All interviews are conducted either in person or virtually, with video required.
About Us
IPS, a Berkshire Hathaway company, is a global leader in technical consulting, architecture, engineering, procurement, construction management, commissioning, qualification, and validation services for technically complex facilities. Integration is how we think and work. It requires the ability to unite existing and emerging technologies into a process that reliably delivers products and accelerates speed to market. That end-to-end mindset allows us to be agile and anticipate challenges as we move projects toward operational readiness. IPS applies design and delivery expertise, client-side experience, and supplier-side insight to every project. We infuse our curiosity, our passion, and our commitment to partnership in delivering solutions at any scale. We meet our clients where they are and get them to where they need to go. That's only possible when we care as much as our clients do.
Specialties
Process Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV, and Staffing Services.
All qualified applicants will receive consideration for employment at IPS without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. IPS is proud to be an affirmative action and equal opportunity employer.
Connect With Us!
If you do not meet the qualifications for this specific role, but would like to submit your resume for general consideration, please click here!
Regulatory Affairs and Compliance Associate
Irvine, CA job
Company: ELIXIR MD Inc.
Industry: Medical Devices (Global Aesthetic & Surgical Markets)
About Us
ELIXIR MD Inc. is a fast-growing fully integrated medical device innovator, headquartered in Irvine, CA. and proud Made in the USA ethos. Our manufacturing, supply, sales and support operations are global with sales in 22 countries (and growing). Our flagship device is transforming the way plastic surgeons practice worldwide. With rapid adoption, global expansion, and highly specialized logistics for a growing portfolio of Devices, we are looking for a Full time Regulatory Affairs and Compliance Associate to help scale our business with precision, creativity, and discipline.
Position Summary
The Regulatory Affairs and Compliance Manager is responsible for ensuring that Elixir MD Inc. operates in full compliance with all applicable federal, state, and local regulations governing medical, healthcare, and corporate operations. This role oversees regulatory strategy, compliance monitoring, licensing, audits, and internal controls helping the company maintain operational integrity and regulatory excellence as it scales.
The ideal candidate has a deep understanding of medical and healthcare regulations, FDA, FTC, HIPAA, OSHA, and state medical board compliance, with a proactive approach to risk mitigation and continuous improvement.
Key Responsibilities
Develop, implement, and maintain company-wide regulatory compliance programs in accordance with FDA, FTC, and state health authority requirements.
Prepare and manage regulatory submissions, renewals, and registrations for company products and services (as applicable).
Stay current with evolving medical, pharmaceutical, and aesthetics industry regulations and communicate updates to leadership.
Liaise with federal and state regulatory agencies, auditors, and external partners when necessary.
Establish and maintain policies, procedures, and systems that ensure compliance with HIPAA, OSHA, state medical board, and corporate regulations.
Conduct regular internal compliance audits and risk assessments; develop corrective action plans as needed.
Monitor company practices related to marketing claims, clinical operations, and professional conduct to ensure compliance with applicable laws and ethical standards.
Review contracts, marketing materials, and operational documents for regulatory accuracy and risk exposure.
Partner with operations and product teams to ensure quality management systems (QMS) align with regulatory expectations.
Support documentation and recordkeeping practices to ensure traceability, accountability, and readiness for inspection.
Oversee incident reporting, CAPA (Corrective and Preventive Actions), and internal investigations.
Develop and deliver compliance training programs to employees, management, and contractors.
Serve as a resource for staff regarding compliance questions, reporting obligations, and best practices.
Promote a company culture centered on ethical conduct, integrity, and accountability.
Lead internal and external audits and coordinate responses to regulatory inspections.
Identify compliance risks and gaps; design and implement strategies to minimize exposure.
Maintain documentation for all regulatory and compliance-related activities to ensure transparency and traceability.
Qualifications
Bachelor's degree in Regulatory Affairs, Life Sciences, Healthcare Administration, or related field (Master's preferred).
5-8 years of experience in regulatory affairs or compliance within the medical, healthcare, or life sciences industry.
Strong understanding of FDA, HIPAA, OSHA, FTC, and state medical board regulations.
Experience preparing and managing regulatory submissions, audits, and compliance reports.
Proven ability to interpret complex regulations and translate them into actionable internal policies.
Excellent written, verbal, and interpersonal communication skills.
High attention to detail, analytical mindset, and professional integrity.
Certifications such as RAC (Regulatory Affairs Certification) or CHC (Certified in Healthcare Compliance) preferred.
Customer Service - Donor Support Technician
Lafayette, LA job
Responsibilities: • Responsible for preparing the donor, donor area and equipment for the pheresis process. • Prepares the autopheresis machine for the pheresis process. • Monitors the donor and the pheresis process, responds to specific alarms or signals that may occur during the process.
• Disconnects the donor when the process is complete.
• Maintains alertness and awareness to any reaction donor may have during or after the pheresis process and notifies appropriate staff.
• Uses Personal Digital Assistant (PDA) to record incidents that occur during the pheresis process, such as machine alerts and alarms, volume variances and donor adverse events.
• Uses PDA to link equipment and soft goods used in the pheresis process to the appropriate donor.
• Alerts Group Leader or Supervisor of donor flow issues.
• Ensures the accurate recording of donor data in the electronic donor information management system as outlined in the Standard Operating Procedures (SOPs).
• Understands the policies and procedures associated with hyper immune programs at the center if applicable.
• Maintains clean efficient work environment, and ensures sufficient operating supplies and forms are available as needed. Follows all Health Safety & Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Promotes safety in all actions.
• Maintains confidentiality of all personnel, donor and center information.
• May be cross-trained in other areas to meet the needs of the business.
• Bilingual skills may be required, at the discretion of the organization, to meet the needs of the business.
• Perform job-related duties as assigned.
Qualifications:
• High school diploma or equivalent required
• Minimum of three (3) months' work experience, preferably in medical or health provider environment or equivalent combination of education and experience
• Must be able to perform basic math calculations
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
Our Benefits
For more information on CSL Plasma benefits visit *****************************
About CSL Plasma
CSL Plasma operates one of the world's largest and most sophisticated plasma collection networks, with over 350 plasma collection centers in the U.S., Europe and China. Headquartered in Boca Raton, Florida, CSL Plasma is a subsidiary of CSL Behring, a global biotherapeutics business and a member of CSL. Plasma collected at CSL Plasma facilities is used by CSL Behring for the sole purpose of manufacturing lifesaving plasma-derived therapies for people in more than 100 countries. The parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people.
We want CSL to reflect the world around us
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. Learn more Inclusion and Belonging | CSL.
Do work that matters at CSL Plasma!
Auto-ApplyRN 7500 sign on bonus
Jefferson City, MO job
We are hiring for a full-time RN to join our passionate team!
7500 sign on bonus
At Central Missouri Home Health, a part of LHC Group we embrace a culture of caring, belonging, and trust and enjoy the meaningful connections that come from it: for the whole patient, their families, each other, and the communities we serve-it truly is all about helping people.
As a Registered Nurse with us, you can expect:
flexibility for true work-life balance
opportunities for career growth
the ability to build trusted nurse-patient relationships
employee-focused wellness and support programs
If you love nursing and want to strengthen your experience, this is a great opportunity for you.
The Registered Nurse (RN) in Home Health provides and directs provisions of nursing care to patients in their homes as prescribed by the physician and in compliance with applicable laws, regulations and agency policies. Also, the Registered Nurse coordinates total plan of care with other health care professionals involved in care and helps to achieve and maintain continuity of patient care by planning and exchanging information with physician, agency personnel, patient, family, and community resources. All done within a Point of Care setting.
Provides clinical services within the scope of practice, as defined by the state laws governing the practice of nursing, in accordance with the plan of care, and in coordination with other members of the health care team.
Makes the initial and|or comprehensive nursing evaluation visit, determines primary focus of care, develops the plan of care within State specific guidelines, and submits accurate, complete, and timely documentation, per policy.
Regularly evaluates and re-evaluates (as warranted by changes in condition but at least every 60 days) the patient's nursing needs.
Performs patient comprehensive assessments at designated time points and develops the appropriate POC, in collaboration with physician orders.
Ensures patients meet home health eligibility and medical necessity guidelines as defined by payer source.
Initiates, develops, implements and makes necessary revisions to the plan of care in collaboration with the physician and other health care professionals involved in care.
License Requirements
Current RN licensure in state of practice
Current CPR certification
Current Drivers License, vehicle insurance, and access to a dependable vehicle or public transportation
By applying, you consent to your information being transmitted by Veritone to the Employer, as data controller, through the Employer's data processor SonicJobs.
See LHC Group Privacy Policy at ***************************** and SonicJobs Privacy Policy at ******************************************* and Terms of Use at *********************************************
PandoLogic. Category:Healthcare, Keywords:Home Health Care Nurse, Location:Jefferson City, MO-65107
Analytical Development Chemist
Cumberland, RI job
The Pharma Method Development and Validation Chemist will perform studies for the development of immediate release and controlled release tablet and capsules dosage formulations, topical formulations (creams and gels) and liquid formulations.
Develop methods per ICH/USP requirements for excipient, API and final formulations of solid oral dosages form.
Writes method protocols for full validation and verifications to USP methods.
Does forced degradation studies.
Can make a method from scratch and or improves such by fine tuning the method parameters to meet USP or vendor specifications.
Works with QC to due testing . However, main job is taking a tech pack and making method validation protocols for submitting into ANDA .
Perform testing on raw materials and in-process and finished dosage forms.
Write technical documents including laboratory notebooks, batch records, project summaries, development reports, sampling and testing protocols, planned deviation reports, incident reports, and change control forms.
Maintain technical documents in the formulation development department.
Calibrate in-process testing equipment, interpret and analyze experimental data, identify the next steps to be taken and perform scale-up and technology transfers of formulations from research and development to the submission/clinical to production/commercial scale batches.
Direct the work of scientists and technicians in the formulation department, reviewing their laboratory notebooks, batch records, project summaries, product development reports and standard operating procedures.
Attend project meetings.
Manage R&D projects and report project progress to the project manager.
Communicate the status of various batches to the production, QA, RA and QC departments and to clients, as needed.
Assist in FDA filings.
Review project contracts.
Assist IT in development and implementation of the database system.
Bachelor's Degree in Chemistry required.
Proficiency in computer usage and Microsoft Office required.
Job Type: Full-time
Required experience: Chemistry: 4 years
Director of Regulatory Affairs
Lincoln, NE job
Job Title: Director of Regulatory Affairs
Department: Clinical & Regulatory
Contribute to advancing robotic-assisted surgery while working for a truly innovative company that respects values and appreciates all team members!
Why you will love working at Virtual Incision:
Strong mission to expand access to robotic-assisted surgery, one of the most exciting fields in healthcare today
Company-wide dedication to clinical excellence, innovation, and teamwork
Friendly, open, and fun culture where people genuinely like each other
Opportunity to take ownership on exciting projects from day one
Career development through fast pace and an all-hands-on-deck culture
Mentorship from some of the top industry experts
Flexible working hours, including an open paid time off policy and holidays
Healthcare programs including medical, dental, vision, disability, and life insurance
401(k) retirement plan
Job Summary:
The Director of Regulatory Affairs is responsible for leading and executing Virtual Incision's U.S. and OUS regulatory programs to support the development, launch, and commercialization of the MIRA Surgical System in a dynamic start-up environment. Acting with a high degree of autonomy, this individual will implement regulatory strategies in close collaboration with Clinical and Medical Affairs and under the guidance of the VP of Clinical and Regulatory Affairs. The Director will serve as a key regulatory voice in cross-functional teams, maintain active engagement with the FDA and global authorities, and remain informed of evolving regulatory requirements, industry trends, and competitive developments to proactively guide company strategy.
Responsibilities:
Implement regulatory strategies to support the company's business objectives across different indications
Oversee the preparation, submission, and maintenance of regulatory filings
Provide regulatory guidance to cross-functional teams (R&D, Clinical, Quality, Marketing, Operations) throughout the product lifecycle
Monitor and analyze trends (FDA, Industry, Compliance Standards etc.) impacting on the regulatory landscape of Virtual Incision's current and future product pipelines
Perform gap assessments and recommend compliance strategies to establish and maintain robust regulatory processes and SOPs to ensure ongoing compliance as requirements evolve
Manage, mentor, and develop team members, fostering a culture of accountability, compliance, and continuous improvement
Represent the company in interactions with regulatory authorities
Stay abreast of company portfolio developments, competitor filings, and regulatory shifts to proactively guide decision-making
Participate in company and industry events such as sales meetings, training programs, trade shows, and other events/duties as requested
Other duties as assigned
Qualifications:
Bachelor's degree in life sciences, engineering, or related field required; advanced degree preferred.
10 years of medical device regulatory experience, with at least 5 years of management experience
Proven track record of successful FDA interactions and approvals (510(k), De Novo, PMA, IDE)
Direct experience writing and leading regulatory filing events (e.g. Q-Submissions, Letters to file, Safety Reporting, IDEs, 510(k), De Novo, CE Mark)
In-depth knowledge of U.S. medical device regulations, including 21 CFR Part 11, Part 820, QSR, and ISO 13485; familiarity with MDR is a plus
Strong execution skills and attention to detail
Strong leadership, communication, and negotiation skills with the ability to influence across all organizational levels.
Must be able to proactively make recommendations, align key stakeholders, and drive to results in a fast-paced environment
Must be able to learn and maintain technical knowledge of Robotic Assisted Surgical procedures, products and activities
Ability to organize and prioritize workflow to meet established timeframes and budgets
Ability to exercise independent judgment consistent with VI's mission and values
Able to work under pressure and travel as needed (maximum 20%)
Fluent in computer applications (e.g., Microsoft Word, Excel, PowerPoint, Windows, Internet applications, etc.) required
Salary: DOE
Status: Exempt
Validation Engineer II
Indianapolis, IN job
At IPS, we are global leaders in developing innovative solutions for the consulting, architecture, engineering, project controls, procurement, construction management, and CQV of technically complex facilities, primarily in the life sciences industry. We are looking for a talented CQV Engineer II to join our team at our office located in _____________.
In this role, you will perform cGMP compliance-based services (commissioning, qualification, validation, consulting, etc.) as developed and defined in project agreements with IPS clients. You will also follow IPS and client standards and requirements, overall good industry practices for C/Q/V services, and regulatory requirements. You may also perform standalone commissioning services for non-FDA-regulated clients.
Additional Responsibilities
Write C/Q/V documents following established standards and templates, including but not limited to the following:
Commissioning Forms
C/Q/V Protocols and Summary Reports
Standard Operating Procedures
Impact Assessments
Specifications (URS/FRS/DDS)
FATS/SATs
Perform field/site activities including, but not limited to, the following:
Attend and witness FATs and SATs as a representative of IPS clients.
Execution of commissioning forms and witnessing of vendor start-up and testing.
Execution of C/Q/V protocols.
Walkdown and verification of system drawings (P&IDs, as-builts, etc.)
Compile data and prepare reports for completed C/Q/V activities including ETOPs, protocol data packages, etc.
Assist in deviation investigation and resolution of problems and issues encountered during field execution activities.
Work with the Project Delivery department or CM for start-up and vendor testing. Witness and troubleshoot as required.
Primary responsibilities include C/Q/V of equipment and systems, including CSV and automation, supporting pharmaceutical, biotech, and medical device industries.
Read, understand, and utilize the IPS Best Practices and SOPs for the delivery of compliance services
Perform work to meet IPS budget requirements and quality standards. Provide consistent, complete, and timely feedback and reports to IPS project leaders, project managers, or management, of project status and issues, as requested.
Come join our dynamic team that creates world-class designs for our clients, and propel your career to new horizons!
Qualifications & Requirements
Bachelor of Science in Engineering.
2+ years of relevant work experience.
This is an entry-level position.
Experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA.
Preferred Qualifications
Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms/protocols for GMP Utilities, Equipment, Systems, and Software.
General exposure and experience in a GMP/Validation discipline with a knowledge and understanding of pharmaceutical Design/Build/Commission/Validation processes and how they relate to regulatory requirements and cGMP regulations within the E.U. and U.S. FDA.
Context & Safety
This position will have up to 100% travel to the site, or as required by the assigned project.
You may be assigned to a client site for an extended period.
Overnight travel or staying in the city of the client's location is possible depending on the assignment.
Travel will be per the IPS Travel Policy, client-specific travel policy, or project-specific travel plan.
You may visit active construction sites and will be required to take site safety training and adhere to site safety rules.
This position is a safety-sensitive position.
The employee is designated for field work and attends activities at client sites where they work in construction, process, packaging, manufacturing, research, or other "non-administrative" areas.
All interviews are conducted either in person or virtually, with video required.
About Us
IPS, a Berkshire Hathaway company, is a global leader in technical consulting, architecture, engineering, procurement, construction management, commissioning, qualification, and validation services for technically complex facilities. Integration is how we think and work. It requires the ability to unite existing and emerging technologies into a process that reliably delivers products and accelerates speed to market. That end-to-end mindset allows us to be agile and anticipate challenges as we move projects toward operational readiness. IPS applies design and delivery expertise, client-side experience, and supplier-side insight to every project. We infuse our curiosity, our passion, and our commitment to partnership in delivering solutions at any scale. We meet our clients where they are and get them to where they need to go. That's only possible when we care as much as our clients do.
Specialties
Process Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV, and Staffing Services.
All qualified applicants will receive consideration for employment at IPS without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. IPS is proud to be an affirmative action and equal opportunity employer.
Connect With Us!
If you do not meet the qualifications for this specific role, but would like to submit your resume for general consideration, please click here!
Full Time Inside Sales Representative; B2B
Englewood Cliffs, NJ job
Alpine Health is a pharmaceutical distributor that supplies independent pharmacies with a full range of Generic Rx drugs, Diabetic Supplies, DME and Home Health Care products, Prescription Vials and Bottles, Pharmacy Supplies and Health and Beauty Aid Products.
Job Description:
This person will be assisting the Outside Sales Representatives with their accounts as well as developing and calling on new accounts by means of both tele-sales and relationship development. Our ideal person must be highly self-motivated, enjoy working with people in a team environment with the ability to work cross-functionally. Hours for this position are from 9:30 AM to 6:30 PM. This is a 1099 position.
Excellent communication skills.
Highly skilled at speaking with customers on the telephone and able to produce high quality work with little oversight.
Place between 80 to 100 outgoing sales calls by phone each day to prospective clients.
Document each communication and create a new, dated follow-up task in our CRM system immediately following each communication.
Impeccable attention to detail in tracking leads.
Participate in brief sales meetings with other Sales Reps and Sales Manager each day.
Consistently meet and exceed goals while maintaining the highest level of integrity.
Continuous interaction and communication with Sr. Sales and Management to keep updated of upcoming programs and changes.
Ability to handle all questions and solve problems with the highest levels of skill.
Sharing best practice skills with the team and to promote a positive team environment.
High volume of outbound/inbound phone calls per day.
Cold calling and lead generated calls.
Key Attributes:
Exceptional outgoing and energetic personality.
Team Player with a sense of group value.
Must consistently and aggressively drive sales.
Self-confident and extremely competitive.
Trustworthy and prideful in their work.
Expert sales skills and ability to lead and motivate by example.
Qualifications:
Minimum 1-3 years of related experience in Business to Business (B2B) Inside Sales or New Business Development.
Proven track record in new sales development.
Strong planning, problem-solving, and negotiation skills.
Excellent oral and written communication skills.
Microsoft Suite experience.
Job Type: Full-time
Pay: $25.00 per hour
Manufacturing Engineering Technician
Bethel, CT job
Eaton's IS AER FED division is currently seeking a Manufacturing Engineering Technician. The hours for this role are 7:00am - 3:30pm is $27.00 - $37.00 per hour. Please note the salary information shown above is a general guideline only. Salaries are based upon candidate skills, experience, and qualifications, as well as market and business considerations.
What you'll do:
Summary:
We are seeking a detail-oriented and mechanically proficient Mechanical Engineering Technician to join our Aerospace Division in Bethel, CT. This role supports the Manufacturing Engineering team in driving process stability, enhancing product quality, and reducing rework cycles across fluid and electrical distribution systems. The ideal candidate will possess strong hands-on mechanical skills, a proactive approach to problem-solving, and a desire to grow into engineering roles. A key component of this role includes supporting Material Review Board (MRB) dispositions, evaluating non-conforming material, and collaborating with cross-functional teams to determine appropriate corrective actions.
Responsibilities:
• Participate in MRB activities by reviewing non-conforming material, documenting findings, and recommending disposition actions.
• Provide technical support and instruction for group leaders and operators on proper assembly techniques
• Assist in developing and implementing mechanical fixturing for repeatable and reliable assembly processes.
• Assist in the investigation of root cause for non-conformities and implementation of corrective action.
• Assists in developing and maintaining robust, cost-efficient manufacturing processes and product structures consistent with lean manufacturing practices.
• Developing and updating manufacturing Visual Work Instructions.
• Implement methods and practices to reduce variation. Demonstrates ability to understand source(s) of variation.
• Promotes a culture of continuous improvement and understands lean manufacturing techniques to focus on process optimization and defect reduction.
• Collaborate with cross-functional teams including Quality, Supply Chain, and Production to resolve technical issues.
• Additional duties as assigned.
Qualifications:
Required Competencies:
• Proficiency in MS Office Word, Excel
• Associate degree or 2-year technical certification or experience in a manufacturing operations/skilled trades from accredited institution
• Minimum of three (3) years' experience in a manufacturing/operations or military environment
• Minimum 1 year of experience in working with the lean tools in a manufacturing environment
• Experience with blueprints/schematics
• Must be legally authorized to work in the United States without company sponsorship.
• This position requires use of information or access to hardware which is subject to the International Traffic in Arms Regulations (ITAR). All applicants must be U.S. persons within the meaning of ITAR. ITAR defines a U.S. person as a U.S. Citizen, U.S. Permanent Resident (i.e. 'Green Card Holder'), Political Asylee, or Refugee.
Preferred Competencies:
• Knowledge of lean manufacturing techniques - i.e. value stream mapping, one piece flow, etc.
• Knowledge of Six Sigma concepts and tools as they relate to minimizing process / product variability
• Understanding of problem-solving methodologies used in determining root cause and formulating corrective action(s) - i.e. thought maps, 8D, root cause analysis, Process Failure Mode Effect Analysis, Gage R & R, control charts, Pareto charts, etc.
• 3D Printing capability
• Tool design utilizing SolidWorks (or similar) CAD software
• Proficiency in MS Office Word, Excel
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We are committed to ensuring equal employment opportunities for all job applicants and employees. Employment decisions are based upon job-related reasons regardless of an applicant's race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, marital status, genetic information, protected veteran status, or any other status protected by law.
Eaton believes in second chance employment. Qualified applicants with arrest or conviction history will be considered regardless of their arrest or conviction history, consistent with the Los Angeles County Fair Chance Ordinance, the California Fair Chance Act and other local laws.
You do not need to disclose your conviction history or participate in a background check until a conditional job offer is made to you. After making a conditional offer and running a background check, if Eaton is concerned about conviction that is directly related to the job, you will be given the chance to explain the circumstances surrounding the conviction, provide mitigating evidence, or challenge the accuracy of the background report.
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We know that good benefit programs are important to employees and their families. Eaton provides various Health and Welfare benefits as well as Retirement benefits, and several programs that provide for paid and unpaid time away from work. Click here for more detail: Eaton Benefits Overview. Please note that specific programs and options available to an employee may depend on eligibility factors such as geographic location, date of hire, and the applicability of collective bargaining agreements.
On-Site Paramedic - EMT-P - Sign-On Bonus Eligible
Biolife Plasma Services job in Muncie, IN
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
$2500 Sign-On Bonus
Please take this virtual tour to get a sneak peek of one of our Plasma Donation Centers.
About BioLife Plasma Services
Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will report to the Plasma Center Manager and will perform as a Medical Support Specialist (Plasma Center Nurse) to support plasma center operations.
BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd.
About the role:
Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will determine donor eligibility to donate plasma, management of donor adverse events, review of laboratory test results, and donor notification of unsuitable test results. The Medical Support Specialist (Plasma Center Nurse) works under the guidance of the Center Manager (or Assistant Manager as applicable) for operational guidance and under the management of the Center Physician for medical issues. The Medical Support Specialist will be familiar with regulations of the plasma collection industry or a manufacturing environment. The Medical Support Specialist follows guidance provided by BioLife Medical Affairs and provides center level support of environmental, health and safety (EHS).
How you will contribute
You will determine donor eligibility; to include, proper management of informed consent, AIDS education and confidential self-exclusion, medical history interview and acceptance requirements, physical examination, blood testing, and reviewing Serological Protein Electrophoresis (SPE).
You will evaluate donor reaction(s), which occurs at the facility as outlined in the SOPs. Follow applicable SOPs for medical emergencies including the development of Center Physician's standing orders and donor transport to emergency care facilities.
You will refer to the Center Physician or Medical Affairs (as applicable) when in need of providing unacceptable findings to donors, or guidance concerning medical or technical issues, including donor safety and eligibility.
You will support the Hepatitis B and Seasonal Flu vaccination programs for employees as applicable.
You will manage employee incidents and determine whether further evaluation is required by occupational health/ER. Refer to EHS guidance regarding employee incidents.
You can be a Pandemic Coordinator when authorized by EHS and support investigations associated with pandemic threats within the local community as indicated by EHS or Medical Affairs.
What you bring to Takeda:
High school diploma or equivalent to including graduate equivalent of a recognized educational nursing program with state requirements
Currently licensed or certified in the state where responsibilities will be assigned: EMT-Paramedic
Current Cardiopulmonary Resuscitation (CPR) and AED certification
Fulfill state requirements (in state of licensure) for basic IV therapy
Satisfactorily complete the FDA approved training requirements for BioLife Medical Support Specialist
Two years in a clinical or hospital setting
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to bring Better Health and a Brighter Future to people around the world.
BioLife Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
USA - IN - Kokomo
U.S. Hourly Wage Range:
$23.85 - $32.79
The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsUSA - IN - KokomoWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Job Exempt
No
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