Staff Product Transfer Project Engineer – Bioprocessing

Wilson•Franklin, TN

12d•Hybrid

About The Position

We are seeking an experienced Staff Product Transfer Project Engineer – Bioproprocessing to provide technical leadership for complex biologics manufacturing technology transfer programs between Contract Manufacturing Organizations and internal manufacturing sites. This role will support sterile injectable biologic drug products and will lead engineering activities across process development, technology transfer, scale-up, qualification, validation, regulatory support, and commercial manufacturing readiness. The successful candidate will serve as a key technical and engineering liaison between external manufacturing partners and internal Technical Operations, Regulatory Affairs, Quality, Manufacturing, Supply Chain, Validation, and cross-functional project teams. This position is well suited for someone with strong biologics manufacturing knowledge, cGMP experience, technical project leadership, and experience supporting technology transfers in FDA-regulated environments.

Requirements

Master’s degree or Ph.D. preferred in Chemistry, Biochemistry, Pharmaceutical Sciences, Biotechnology, Engineering, or a related scientific or technical discipline. Bachelor’s degree may be considered with significant relevant experience.
Minimum of 4 years of engineering experience in biotechnology, biologics, pharmaceutical, medical device, or other highly regulated industries.
Minimum of 4 years of experience supporting technology transfer, manufacturing engineering, process engineering, validation, or scale-up in FDA-regulated cGMP environments.
Experience supporting biologics manufacturing, bioprocessing, sterile manufacturing, or injectable drug product operations.
Strong technical writing, documentation, and communication skills.
Strong project management, organizational, and stakeholder-influence skills.
Ability to work effectively in highly regulated environments.
Ability to travel domestically and internationally up to 25%, depending on project needs.
Ability to work in a hybrid role based in Franklin, Tennessee.

Nice To Haves

Experience working with Contract Manufacturing Organizations.
Scientific leadership experience in GMP biologics manufacturing.
Experience with sterile injectable biologic drug products.
Experience supporting BLA supplements, regulatory submissions, inspection readiness, or post-approval manufacturing changes.
Experience with upstream and downstream bioprocessing.
Experience with single-use systems, protein formulation, stability, and analytical methods.
Experience supporting analytical test method transfers.
Experience reviewing or executing IQ, OQ, PQ, PPQ, engineering runs, GMP, and non-GMP campaign documentation.
Experience with ECOs, change control systems, documentation release, and technical transfer governance.
Experience using FMEA or similar structured risk assessment tools.

Responsibilities

Lead end-to-end bioprocess technology transfer activities between external manufacturing partners and internal manufacturing sites.
Support process adaptation, scale-up, equipment qualification, validation, and commercial readiness activities.
Provide technical leadership for sterile injectable biologic drug product transfer programs.
Partner with internal and external teams to ensure transfer activities are executed in alignment with technical, quality, regulatory, and project requirements.
Identify technical risks, project dependencies, process gaps, and execution challenges throughout the transfer lifecycle.
Support successful transition of products and processes into commercial manufacturing.
Serve as the primary engineering liaison between Contract Manufacturing Organizations and internal teams.
Collaborate with Technical Operations, Regulatory Affairs, Quality, Manufacturing, Supply Chain, Validation, and external partners.
Lead technical discussions with internal teams and external manufacturing partners.
Communicate project status, risks, technical issues, and recommendations to leadership and stakeholders.
Drive issue resolution and ensure alignment across functions during transfer, qualification, validation, and manufacturing readiness activities.
Build strong working relationships with CMOs and internal stakeholders to support timely project execution.
Conduct engineering gap assessments to identify technical, process, equipment, validation, or documentation risks.
Perform technical risk evaluations using structured methodologies such as FMEA.
Support root-cause analysis and technical investigations related to process transfer, qualification, validation, or manufacturing readiness challenges.
Develop recommendations to address technical gaps and reduce transfer risk.
Ensure engineering decisions are supported by sound technical rationale, data, and regulatory expectations.
Support IQ, OQ, PQ, GMP, non-GMP, engineering, and PPQ campaign execution.
Review protocols, reports, batch records, validation documentation, technical records, and transfer documentation.
Ensure documentation aligns with regulatory expectations, quality standards, project timelines, and internal procedures.
Support analytical test method transfer activities as needed.
Partner with validation, quality, manufacturing, and technical teams to confirm readiness for process execution and commercial production.
Provide technical support during manufacturing campaigns, process qualification, and post-transfer activities.
Support regulatory submissions and technical documentation related to manufacturing transfers.
Provide technical input for Biologics License Application supplements, inspection readiness, and regulatory justifications.
Support documentation and technical rationale for post-approval manufacturing changes.
Ensure transfer and engineering activities comply with FDA, EMA, ICH, cGMP, and applicable regulatory expectations.
Support inspection readiness through documentation review, technical explanations, and cross-functional preparation.
Manage engineering change strategies, ECOs, and documentation release activities through change control systems.
Support change control planning and execution for process, equipment, documentation, analytical method, and manufacturing transfer changes.
Prepare, review, and maintain technical documentation, risk assessments, reports, protocols, and project records.
Ensure documentation is accurate, complete, traceable, and aligned with quality and regulatory requirements.
Perform additional duties as assigned to support Product Transfer and Technical Operations.