Senior Process Engineer
Core
Hands-on engineering role supporting the introduction of new biopharmaceutical products, focusing on liquid formulations produced under single-use systems in a cleanroom environment.
Role type
Senior Process Engineer (Bioprocess Equipment)
Builds
Biopharmaceutical products (AAV, viral vector-based therapies, vaccines) via liquid formulations
Domain
Biopharmaceutical manufacturing / Gene Therapies
Deliverable
physical/clinical work
Required skills
Bioprocess equipment troubleshooting, Preventive maintenance, Commissioning and qualification (IQ/OQ), GMP documentation, Root cause analysis, Vendor management, SCADA integration
Preferred skills
Aseptic processing, Fill/finish operations, Cell culture, Fermentation, Medical device manufacturing
Technologies
SCADA, CMMS, Single-use systems
Responsibilities
Troubleshoot bioreactors, fermenters, chromatography skids, centrifuges, fillers, isolators, and utility systems; Execute preventive maintenance programs; Lead installation of new equipment and support commissioning/qualification; Prepare and review GMP documentation (change controls, deviations, CAPAs); Perform root cause investigations and risk assessments; Train operators and support regulatory inspections.
Seniority
Senior, hands-on IC