Senior Specialist, Validation Engineer - CSV
Core
Qualify Process Control System (DeltaV) and Manufacturing Execution System (MES) configurations for clinical and commercial biologics manufacturing facilities.
Role type
Senior Specialist Validation Engineer (CSV)
Builds
GMP-compliant manufacturing systems and automation configurations
Domain
Biopharmaceutical manufacturing / Process Automation
Required skills
Process automation system software testing, DeltaV batch system experience, DCS and PLC experience, cGMP and regulatory guidelines knowledge, validation protocol generation and execution, change control management, technical writing
Preferred skills
Lean principles, large scale distributed control systems experience
Responsibilities
Execute validation efforts for GMP manufacturing systems, manage test protocol generation and execution for configuration changes, assess and execute validation work from change controls and capital projects, provide validation support to multi-function teams, ensure alignment with industry guidelines
Seniority
Senior, hands-on IC