Staff Product Transfer Project Engineer – Bioprocessing

We are hiring Staff Product Transfer Project Engineer – Bioprocessing.

Please let me know if you are interested or anyone who might be interested.

Client: Major Medical Device Client

Position: Staff Product Transfer Project Engineer – Bioprocessing

Duration: 18 months on W2

Location: Franklin, Tennessee 37067

Pay Rate: $50.00-$60.00/ Hr on W2

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Job Description

Schedule:

• Regular working hours (1st Shift): 8:00 AM – 5:00 PM
• Hybrid: Minimum 3 days onsite

Position Summary

The Staff Product Transfer Project Engineer – Bioprocessing provides technical leadership for complex biologics manufacturing technology transfer programs between Contract Manufacturing Organizations (CMOs) and internal manufacturing sites.

This role supports sterile injectable biologic drug products by leading engineering activities and providing technical support across process development, technology transfer, qualification, validation, regulatory support, and commercial manufacturing readiness.

Key Skills & Knowledge

• Strong understanding of biologics manufacturing, upstream and downstream bioprocessing, sterile manufacturing, single-use systems, protein formulation, stability, and analytical methods.
• Working knowledge of FDA, EMA, ICH, cGMP requirements, process validation lifecycle, regulatory submissions, and post-approval manufacturing changes.
• Excellent project management, technical writing, communication, organizational, and stakeholder management skills within highly regulated environments.

Key Responsibilities

• Lead end-to-end bioprocess technology transfer activities, including process adaptation, scale-up, equipment qualification, validation, and commercial manufacturing 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 cross-functional teams and external partners to lead technical discussions, resolve issues, communicate project status, identify risks, provide recommendations to leadership, and ensure successful execution of technology transfer activities.
• Conduct engineering gap assessments and technical risk evaluations using structured methodologies such as FMEA.
• Support regulatory submissions, BLA supplements, inspection readiness, and technical justifications related to manufacturing transfers.
• Support analytical test method transfer activities, IQ, OQ, PQ, GMP and non-GMP engineering activities, and PPQ campaign execution, including review of protocols, reports, batch records, and technical documentation to ensure compliance with regulatory requirements, quality standards, and project timelines.
• Manage engineering change strategies, ECOs, and documentation release activities through change control systems.
• Perform other duties as assigned in support of Product Transfer and Technical Operations.

Required Qualifications

• Preferred: M.S. or Ph.D. in Chemistry, Biochemistry, Pharmaceutical Sciences, Biotechnology, or Engineering.
• B.S. degree will be 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.
• Experience working with Contract Manufacturing Organizations (CMOs) is preferred.
• Scientific leadership experience in GMP biologics manufacturing is preferred.

Travel

• Domestic and international travel up to 25%, depending on project phase.