Process Engineer - CIP/ SIP/ Autoclave
Core
Design, build, commission, and qualify CIP/SIP/autoclave systems for biopharmaceutical drug substance production.
Role type
Senior IC Process Engineer (Facilities & Engineering)
Builds
Drug substance manufacturing systems and equipment
Domain
Biopharmaceutical manufacturing / Chemical Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CIP/SIP system design and validation, autoclave operation and maintenance, GMP compliance, capital project oversight, troubleshooting, lifecycle support, engineering assessments, maintenance program development
Preferred skills
Chemical or Mechanical Engineering degree, 3+ years biopharmaceutical operations experience, data-driven problem solving (RCA, SPC, Six Sigma), regulatory environment familiarity, system modification implementation
Technologies
CIP skid systems, SIP circuits, autoclaves, transfer panels, process tanks, valves, instrumentation, automation platforms
Responsibilities
Support commissioning and qualification of manufacturing systems in alignment with GMP requirements, demonstrate technical expertise for CIP/SIP/autoclave systems lifecycle support, ensure systems operate safely and comply with environmental health/safety regulations, interact with regulatory inspectors to demonstrate compliance, assist with new product/technology introductions via engineering assessments and equipment modifications, develop equipment maintenance programs and coordinate spare parts availability
Seniority
Mid-Senior, hands-on IC