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)

Position Overview

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).

Key Responsibilities

• 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.

Required Qualifications

• 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.

Preferred Qualifications

• 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.

Additional Information

• 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.