System Validation Specialist

• 5+
• Morris Plains, NJ

Job Description

• Role Overview: We are looking for a Computer System Validation (CSV) Specialist to join our team. You will be responsible for reviewing System Life Cycle (SLC) documentation and may occasionally create summary report documentation. You'll work closely with management as the Validation Lead and collaborate with IT, engineering, and other teams.
  
  Key Responsibilities:
  
  • Review SLC documents like requirement and design specs, Installation Qualifications (IQs), Operational Qualifications (OQ tests), traceability matrices, and User Acceptance Testing (UAT) test scripts.
  • Occasionally draft summary report documentation.
  • Collaborate with various departments, including IT and engineering.
  Required Experience:
  
  • Familiarity with ISA 88/95 Control Systems.
  • Proven experience with CSV strategies.
  • Knowledge of 21 CFR Part 11.
  • Experience in reviewing and approving validation plans, test scripts, and summary reports.
  Preferred Experience:
  
  • Background in Pharma Biologics or CAR-T.
  • Familiarity with DeltaV and ValGenesis.