Senior Specialist, Validation Engineer - CSV
Core
Qualify and validate Process Control Systems (DeltaV) and Manufacturing Execution Systems (MES) for clinical and commercial biologics manufacturing facilities.
Role type
Senior Specialist Validation Engineer (CSV)
Builds
Validated GMP manufacturing systems and automation configurations
Domain
Biopharmaceutical manufacturing / Process Automation
Deliverable
production ML models | product features | dashboards & analysis | infrastructure
Required skills
Process automation system software testing, DeltaV batch system experience, DCS and PLC experience, cGMP and regulatory guideline knowledge, validation protocol generation and execution, change control management, technical writing, project management
Preferred skills
Large scale distributed control systems experience, lean principles
Technologies
DeltaV, Syncade, DCS, PLC
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
