Requalification Lead

Role Summary

The Requalification Lead will drive the strategy, execution, and oversight of equipment and facility requalification activities. This position is responsible for maintaining the validated state of GMP facilities, ensuring compliance with FDA, EMA, and PIC/S regulations, and supporting continuous process verification. The candidate must be capable of establishing the overall requalification approach, defining review cycles and assessment methodologies, prioritizing systems based on risk, and ensuring continued maintenance of the validated state across a broad portfolio of equipment, facility, and utilities.

Key Responsibilities

• Develop, implement, and manage the equipment requalification lifecycle (IQ/OQ/PQ), including CTU qualification and continued process verification.
• Establish and maintain qualification protocols and schedules for process support equipment (autoclaves, sterilizers, washers, refrigerators, freezers, cold storages, incubators).
• Lead requalification efforts for clean utilities (WFI, Purified Water, Clean Steam, Process air/gas).
• Oversee cleanroom environmental monitoring (EM) requalification and inspection readiness.
• Conduct risk assessments to prioritize systems and define appropriate requalification strategies.
• Collaborate with cross-functional teams (Quality Assurance, Engineering, Validation) to ensure alignment and compliance.
• Maintain and ensure data integrity throughout all qualification documentation and processes.
• Facilitate inspection readiness in accordance with FDA, EMA, and PIC/S regulatory expectations.
• Identify gaps, develop action plans, and lead initiatives to resolve qualification-related issues.
• Support facility and utility qualification and requalification across global sites (remote work, with ad hoc travel as needed).

Required Qualifications

• Bachelor’s degree (or higher) in Engineering, Life Sciences, or related field.
• Minimum 10 years’ experience in GMP equipment qualification and lifecycle management.
• Extensive knowledge of equipment requalification, IQ/OQ/PQ, CTU qualification, and continued process verification.
• Deep understanding of GMP compliance, data integrity principles, and regulatory expectations (FDA, EMA, PIC/S).
• Hands-on experience with process support equipment, clean utilities, cleanrooms, and environmental monitoring.
• Strong risk assessment and management skills.
• Demonstrated leadership in defining requalification strategies and inspection readiness.
• Exceptional written and verbal communication skills.
• Ability to work independently in a remote setting, with willingness to travel as required.
• Proven success in cross-functional collaboration and change management.