Back to all Primary Recruiting Services jobs

Posted: Fri Apr 07 2023

Validation Manager

baskataway, New Jersey

Direct Hire

  • Responsible for validation programs in support of GMP manufacturing
  • Responsible for facility, utility and equipment qualification programs
  • Responsible for QA role in process and assay validation programs
  • Review or author validation related documents such as design specification, URS, FAT, SAT, IQ, OQ, PQ for utility and equipment
  • Assume QA lead role in software validation
  • Maintain and update validation master plans
  • Execute validation protocols as required
  • Oversee QA aspects of calibration and preventive maintenance programs used in GMP manufacturing
  • Supervisor, mentor validation staff with the goal of building a sustaining validation team
  • Serve as the primary QA representative for interaction with internal function departments and contractor on validation activities


  • BS/MS in life science or related field
  • 12+ years experience in drug/biologics industry in GMP production environment in roles of validation/engineering
  • 10+ years experience in facility, utility, equipment, instrument validation
  • Experience in biotechnology facility validation is required
  • Familiar with GMP operational principles and practices
  • QC experience helpful
  • Works independently, self-motivated, and results oriented


Primary Recruiting Services