Validation Manager

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