Project Engineer

Project Engineer - Bioprocess Technology Transfer
3 days a week on-site - Franklin, TN

Our client, a leader in manufacturing, is seeking a Project Engineer to support the transfer of a manufacturing process from one contract manufacturer to another. This engineer will serve as the primary technical liaison between the external Contract Manufacturing Organization (CMO) and the client's internal cross-functional teams throughout the technology transfer, supporting sterile injectable biologic drug products across process development, transfer, qualification, validation, regulatory support, and commercial manufacturing readiness.

Responsibilities

• Lead and support end-to-end bioprocess technology transfer activities, including process adaptation, scale-up, equipment qualification, validation, and commercial readiness
• Coordinate manufacturing setup and execution with the CMO
• Serve as the primary engineering liaison between the CMO and internal Operations, Manufacturing, Quality, Regulatory Affairs, Product Management, and Project Management teams
• Partner closely with the assigned Project Manager throughout the duration of the project
• 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 transfer activities, IQ, OQ, PQ, GMP, non-GMP, engineering, and PPQ campaign execution - including review of protocols, reports, batch records, and technical documentation to ensure compliance with regulatory expectations, quality standards, and project timelines
• Manage engineering change strategies, ECOs, and documentation release activities through change control systems
• Perform other duties as assigned to support Product Transfer and Technical Operations

Required Qualifications

• Master's or Ph.D. in Chemistry, Biochemistry, Pharmaceutical Sciences, Biotechnology, or Engineering preferred, with ~4+ years of relevant experience; Bachelor's degree candidates considered with additional relevant industry experience beyond 4 years
• 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 bioprocessing/manufacturing expertise is the highest priority - more critical than prior technology transfer experience, though transfer experience is preferred
• Experience working with CMOs and in regulated biologics environments strongly preferred

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 - this product is managed under a BLA, making regulatory interaction a significant component of the role
• Excellent project management, technical writing, communication, organizational, and cross-functional stakeholder-influence skills in highly regulated environments

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