Staff Product Transfer Project Engineer – Bioprocessing

Location: Franklin, TN (Hybrid – 3 days onsite)

Duration: 18-Month Contract (Potential Extension)

Travel: Up to 25% (Includes 2–3 international trips to Austria during the project)

We are seeking a Staff Product Transfer Project Engineer – Bioprocessing to lead technology transfer activities for biologic drug products between external manufacturing partners and internal manufacturing sites. This individual will serve as the primary engineering liaison across cross-functional teams, ensuring successful product transfer, process validation, regulatory compliance, and commercial manufacturing readiness.

The ideal candidate has strong experience in biologics manufacturing
, bioprocess engineering
, and technology transfer within an FDA-regulated cGMP environment. This is a highly collaborative role requiring close interaction with Technical Operations, Quality, Manufacturing, Regulatory Affairs, Validation, Supply Chain, and external Contract Manufacturing Organizations (CMOs).

• Lead end-to-end product and technology transfer activities for biologics manufacturing.
• Serve as the primary engineering liaison between external manufacturing partners (CMOs) and internal cross-functional teams.
• Support process transfer, scale-up, equipment qualification, process validation, and commercial manufacturing readiness.
• Conduct engineering risk assessments and technical gap analyses using tools such as FMEA.
• Collaborate with Regulatory Affairs to support submissions, inspection readiness, and manufacturing change documentation.
• Support analytical method transfers, IQ/OQ/PQ activities, PPQ campaigns, and review validation protocols and technical documentation.
• Drive engineering change control activities, including ECOs and document management.
• Communicate project status, technical risks, and recommendations to project stakeholders and leadership.

• Bachelor's degree in Engineering, Biotechnology, Biochemistry, Pharmaceutical Sciences, Chemistry, or a related scientific discipline required.
• Master's or Ph.D. preferred with at least 4 years of relevant industry experience.
• Candidates with a Bachelor's degree should have more than 4 years of relevant experience in biologics or pharmaceutical manufacturing.
• Experience in biologics, biotechnology, pharmaceutical, or medical device manufacturing.
• Hands‑on experience supporting technology transfer, manufacturing engineering, process engineering, validation, or process scale‑up.
• Experience working in FDA-regulated cGMP manufacturing environments.
• Strong understanding of biologics manufacturing and bioprocessing.

• Experience working with Contract Manufacturing Organizations (CMOs).
• Knowledge of upstream and downstream bioprocessing.
• Experience with sterile injectable biologics manufacturing.
• Familiarity with FDA, EMA, ICH, cGMP, and process validation requirements.
• Strong project management and cross-functional leadership skills.

• Hybrid work schedule with 3 days onsite in Franklin, TN.
• Remote interviews are available.
• International travel to Austria is expected approximately 2–3 times during the project.
• This is an 18-month contract with the possibility of extension; conversion to a permanent position is not anticipated.