CSV Engineer Biologics 80-100% (m/f/d)
Core
Generation and execution of validation for computerized systems on process engineering equipment and facilities for biologics manufacturing.
Role type
CSV Engineer (Computerized System Validation)
Builds
Validated computerized systems for biologics process engineering equipment and facilities
Domain
Biologics manufacturing / Life Sciences / Regulated Environment
Required skills
Computerized System Validation (CSV), GMP compliance, deviation management, CAPA management, project coordination, audit preparation, process optimization
Preferred skills
KNEAT, COMOS, DMS, TrackWise, SAP, German language skills
Technologies
KNEAT, COMOS, DMS, TrackWise, SAP
Responsibilities
Prepare commissioning and validation documents for new systems; supervise deviations, changes, and CAPAs; coordinate CSV executions with internal and external groups; present CSV documents during audits; schedule and report CSV activities; align CSV strategy with QA CSV.
Seniority
Mid-Senior level (requires significant experience)