Demo

Validation Manager

Primary Recruiting Services
Jersey, NJ Full Time
POSTED ON 1/14/2025
AVAILABLE BEFORE 4/10/2025

Responsibilities

  • 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

Qualification

  • 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
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