Staff Engineer, Engineering

Job Description:
The Staff Product Transfer Project Engineer Bioprocessing provides technical leadership for complex biologics manufacturing technology transfer programs between Contract Manufacturing Organization (CMOs) and internal manufacturing sites. The role supports sterile injectable biologic drug products by leading engineering activities and providing technical support across process development, transfer, qualification, validation, regulatory support, and commercial manufacturing readiness.

Key Skills and 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-influence skills in highly regulated environments.

Key Responsibilities:
Lead end-to-end bioprocess technology transfer activities, including process adaptation, scale-up, equipment qualification, validation, and commercial 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 internal cross-functional teams and external partners to lead technical discussions, resolve issues, communicate project status, risks, and recommendations to leadership, and ensure successful execution of transfer activities.
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 transfers 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:
Preferred M.S. or Ph.D. in Chemistry, Biochemistry, Pharmaceutical Sciences, Biotechnology, or Engineering; B.S. 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 Organization (CMOs) and scientific leadership experience in GMP biologics manufacturing are preferred.

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