• Generate and execute validation lifecycle documentation (FAT, SAT, IOQ, PQ) for equipment, utilities, facilities, cleaning processes, shipping systems, and other GMP‑regulated assets. • Support validation activities for internal and client tech transfer projects, including authoring, executing, reviewing, and closing validation documents such as risk assessments, validation plans, IQ, OQ, PQ, test methods, and validation reports. • Write, review, and revise qualification and verification documents, including SOPs, master validation plans, execution plans, URS, FRS, design specifications, FAT documentation, verification protocols, and commissioning test procedures. • Prepare 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 P&ID walkdowns to verify installation and system readiness. • Conduct thermal mapping of temperature‑controlled chambers, warehouses, and SIP processes. • Support resolution of regulatory observations, audit findings, and manufacturing site issues related to validation. • Perform periodic reviews and requalification activities for temperature‑controlled systems and other validated assets.