Project Engineer
IntePros
Project Engineer - Bioprocess Technology Transfer (Contract)
Location: Hybrid, 3 days a week on-site - Franklin, TN Position Overview
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.
Key Responsibilities
Location: Hybrid, 3 days a week on-site - Franklin, TN Position Overview
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.
Key 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
- 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
- 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
Vacancy posted 5 days ago
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