Genesis10 is currently seeking a Staff Product Transfer Project Engineer - Hybrid for an 18+ month contract position with a Global Medical Technology Company located in Franklin, TN. This role provides technical leadership for complex biologics manufacturing technology transfer programs between Contract Manufacturing Organizations (CMOs) and internal manufacturing sites. The position supports sterile injectable biologic drug products by leading engineering activities and providing technical support across process development, transfer, qualification, validation, regulatory support, and commercial manufacturing readiness.
Responsibilities: - Lead end-to-end bioprocess technology transfer activities, including process adaptation, scale-up, equipment qualification, validation, and commercial readiness
- Serve as the primary engineering liaison between external manufacturing partners and internal Technical Operations, Regulatory Affairs, Quality, Manufacturing, Supply Chain, and Validation teams
- Collaborate with internal cross-functional teams and external partners to lead technical discussions, resolve issues, and communicate project status, risks, and recommendations to leadership
- Conduct engineering gap assessments and technical risk evaluations using structured methodologies such as FMEA
- Support regulatory submissions, Biologics License Application (BLA) supplements, inspection readiness, and technical justifications related to manufacturing transfers
- Support analytical test method transfers activities, IQ, OQ, PQ, GMP, non-GMP, engineering, and PPQ campaign execution
- Manage engineering change strategies, ECOs, and documentation release activities through change control systems
Requirements: - M.S. or Ph.D. in Chemistry, Biochemistry, Pharmaceutical Sciences, Biotechnology, or Engineering preferred; B.S. considered with significant relevant experience
- Minimum 4 years of engineering experience in biotechnology, biologics, pharmaceutical, or medical device industries
- Minimum 4 years supporting technology transfer, manufacturing engineering, process engineering, validation, or scale-up in FDA-regulated cGMP environments
- Strong understanding of biologics manufacturing, upstream and downstream bioprocessing, sterile manufacturing, and single-use systems
- Working knowledge of FDA, EMA, ICH, cGMP requirements, and process validation lifecycle
- Excellent project management, technical writing, communication, and organizational skills
Desired skills: - Experience working with Contract Manufacturing Organizations (CMOs)
- Scientific leadership experience in GMP biologics manufacturing
- Ability to travel domestically and internationally up to 25%
Pay range: $48.08 - $58.08 per hour
Only candidates available and ready to work directly as Genesis10 employees will be considered for this position. If you have the described qualifications and are interested in this exciting opportunity, please apply! Ranked a Top Staffing Firm in the U.S. by Staffing Industry Analysts for six consecutive years, Genesis10 puts thousands of consultants and employees to work across the United States every year in contract, contract-for-hire, and permanent placement roles. With more than 300 active clients, Genesis10 provides access to many of the Fortune 100 firms and a variety of mid-market organizations across the full spectrum of industry verticals.
For contract roles, Genesis10 offers the benefits listed below. If this is a perm-placement opportunity, our recruiter can talk you through the unique benefits offered for that particular client. Benefits of Working with Genesis10: - Access to hundreds of clients, most who have been working with Genesis10 for 5-20+ years.
- The opportunity to have a career-home in Genesis10; many of our consultants have been working exclusively with Genesis10 for years.
- Access to an experienced, caring recruiting team (more than 7 years of experience, on average.)
- Behavioral Health Platform
- Medical, Dental, Vision
- Health Savings Account
- Voluntary Hospital Indemnity (Critical Illness & Accident)
- Voluntary Term Life Insurance
- 401K
- Sick Pay (for applicable states/municipalities)
- Commuter Benefits (Dallas, NYC, SF, and Illinois)
For multiple years running, Genesis10 has been recognized as a Top Staffing Firm in the U.S., as a Best Company for Work-Life Balance, as a Best Company for Career Growth, for Diversity, and for Leadership, amongst others. To learn more and to view all our available career opportunities, please visit us at our website.
Genesis10 is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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