Product Transfer Project Engineer - Hybrid

Staff Product Transfer Project Engineer
- Hybrid

Genesis
10 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 - $57.21 per hour

Only candidates available and ready to work directly as Genesis
10 employees will be considered for this position.

If you have the described qualifications and are interested in this exciting opportunity, please apply!