Senior Engineer
Core
Provide engineering support for Drug Substance facilities, leading equipment upgrades, maintenance, commissioning, and troubleshooting to ensure safe, compliant production.
Role type
Senior IC manufacturing engineer (biopharmaceutical production)
Builds
Drug Substance production systems and equipment
Domain
Biopharmaceutical manufacturing / GMP facilities
Required skills
GMP quality systems, equipment design and specification, root cause analysis, capital project execution, validation, continuous improvement, safety compliance
Preferred skills
Biopharmaceutical operations experience, statistical process control, predictive maintenance, change control, technical writing
Technologies
cell culture reactors, chromatography, filtration, lyophilization, CIP systems, autoclaves, water for injection systems
Responsibilities
Lead implementation of engineering improvements and upgrades; direct equipment maintenance and troubleshooting; ensure commissioning and qualification; develop metrics for system performance; support new product introductions; determine and close CAPAs; apply continuous improvement techniques
Seniority
Senior, hands-on IC