Computer System Validation Specialist - Engineering Human Health (m/w/d)
Core
Responsible for automated production plants and computerized systems in a highly regulated pharmaceutical environment, ensuring safe, efficient, and GMP-compliant operation. (via careerplan.io/jobs/R419030-1-computer-system-validation-specialist-engineering-human-health-mwd-at-msd)
Role type
Computer System Validation (CSV) and Automation Engineering Specialist
Builds
Automated production lines and computerized systems for vaccine manufacturing
Domain
Pharmaceutical manufacturing / Industrial Automation
Required skills
Automation engineering, PLC programming, Control systems integration, Computer System Validation (CSV), Lifecycle documentation, Risk analysis, GMP compliance, Data integrity
Preferred skills
Siemens S7/TIA Portal, HMI systems, Lean principles, Continuous improvement
Responsibilities
Maintain and develop automated production plants, Plan and execute qualification and validation activities, Create and maintain lifecycle documents (URS, risk analyses, test documentation), Analyze technical problems in production environments, Identify and implement optimization potentials
Seniority
Mid-level, hands-on IC
