Validation Manager

Validation Manager – Langhorne, PA

The Validation Manager will oversee the site’s validation programs covering facilities, utilities, equipment, and processes to ensure all systems operate in compliance with cGMP, FDA, EMA, and Quality System requirements. This position will manage the planning, execution, and documentation of commissioning, qualification, and validation (C&Q) activities, supporting both new installations and ongoing requalification efforts. The ideal candidate will bring hands-on experience in autoclave and sterile systems validation and serve as a technical leader ensuring process readiness and data integrity across the site.

• This position’s responsibilities will include, but not be limited to the following:Develop, execute, and maintain validation master plans, protocols (IQ/OQ/PQ), and summary reports in alignment with Quality and regulatory expectations.
• Lead the validation of autoclaves, dehydrogenation tunnels, lyophilizers, cleanrooms, and other critical sterile manufacturing systems.
• Manage validation schedules, personnel assignments, and project timelines to support manufacturing and engineering objectives.
• Compile and interpret commissioning and qualification data; prepare clear, compliant final reports.
• Conduct troubleshooting and impact assessments for deviations, equipment changes, and atypical conditions.
• Provide scientific rationale and technical strategies for validation of new or modified GMP processes and equipment.
• Ensure validation activities adhere to company policies, safety standards, and cGMP documentation practices.
• We are looking for applicants with:Bachelor’s degree in engineering, Life Sciences, or a related technical discipline (advanced degree preferred).
• 7 years of progressive validation experience in a GMP pharmaceutical or biopharmaceutical environment, including 2 years in a supervisory or project leadership capacity.
• Strong knowledge of cGMPs, GDPs, and regulatory requirements as they relate to qualification and validation (IQ/OQ/PQ).
• Hands-on experience with autoclave qualification required; tunnel, lyophilization, and terminal sterilization validation strongly preferred.
• Excellent analytical and problem-solving skills with strong attention to detail and data accuracy.
• Demonstrated ability to plan, manage, and execute multiple validation projects simultaneously in a fast-paced, regulated environment.