Engineer Process Development Environmental & Contamination Control
Core
Engineer Process Development Environmental & Contamination Control supporting commercial biologic and biosimilar medicine manufacturing programs.
Role type
Senior IC process development engineer (environmental contamination control)
Builds
Commercial bulk drug manufacturing facilities for biologic and biosimilar medicines
Domain
Biopharmaceutical manufacturing / Environmental Contamination Control
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Engineering principles, statistical analysis, design of experiments, troubleshooting, process optimization, regulatory compliance (cGMP), deviation resolution, change control, process validation documentation
Preferred skills
Biopharmaceutical manufacturing experience, upstream/downstream operations knowledge, EBR/DeltaV systems, CAPA management, cross-functional collaboration
Technologies
EBR, DeltaV
Responsibilities
Provide real-time technical support to manufacturing operations, monitor process performance and operational trends, apply engineering principles to investigate processing issues, support regulatory and quality activities including process validation, collaborate with cross-functional partners, contribute to global regulatory filings
Seniority
Mid-to-Senior, hands-on IC
