Senior Process Engineer
Core
Leading process engineering analysis, technology transfer, and scale-up strategy for microbial fermentation, synthetic small molecules, and sterile filling in a GMP-regulated pharmaceutical manufacturing environment.
Role type
Senior Process Engineer (Manufacturing)
Builds
Commercial-scale active pharmaceutical ingredients (APIs) including ADC, HPAPI, plasmid DNA, mRNA, and LNP.
Domain
Biopharmaceuticals / Advanced Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process engineering analysis, technology transfer, scale-up strategy, Critical Process Parameters (CPP) and Critical Quality Attributes (CQA) identification, process flow diagramming, mass balance calculations, equipment design and procurement, project management, HAZOP and P&ID review, troubleshooting process equipment, startup of new equipment and instrumentation.
Preferred skills
Post-graduate certification or license in relevant field.
Technologies
GMP-regulated manufacturing systems, fermentation technologies, sterile filling equipment, instrumentation.
Responsibilities
Ensure robust systems for technology transfer risk mitigation; lead process engineering analysis for cycle time and equipment fit; partner with cross-functional teams on technical feasibility; identify and qualify Critical Process Parameters and Control strategies; develop process flow diagrams and mass balances; execute project deliverables within budget and schedule; review process metrics for improvements; design and procure new pharmaceutical processes and equipment; lead departmental quality programming and procedures; troubleshoot process equipment to improve efficiency; perform hands-on startup and commissioning of new equipment; participate in design reviews and client meetings.
Seniority
Senior, hands-on IC
