- Lead the generation and execution of validation lifecycle documentation (FAT, SAT, IOQ, PQ) for equipment, utilities, facilities, cleaning processes, shipping systems, and other GMP‑regulated assets.
- Oversee validation activities for internal and client tech transfer projects, including authoring, executing, reviewing, and closing validation documents.
- Write, review, and revise qualification and verification documents, including SOPs, validation master plans, URS, FRS, design specifications, FAT, and commissioning test procedures.
- Prepare comprehensive summary reports for validation, verification, commissioning, and requalification activities.
- Develop and support procedures, investigations, protocols, reports, and change controls for Maintenance, Engineering, and Quality functions.
- Perform and oversee thermal mapping of temperature‑controlled chambers, warehouses, and SIP processes.
- Support resolution of regulatory observations, audit findings, and manufacturing site issues related to validation.
- Provide technical mentorship and guidance to junior validation staff.