Senior Manager – MSAT (Validation)

About the role

Julphar is seeking a Senior Manager to lead MSAT (Manufacturing Site Acceptance Testing) validation activities. The role oversees the full validation lifecycle, ensuring equipment, facilities, utilities and computerized systems meet regulatory and quality standards.

Key responsibilities

• Manage equipment, facility and utilities qualification using the V‑Model from URS through FAT, SAT, IQ, OQ and PQ, including re‑qualification.
• Ensure clean‑room qualifications comply with ISO‑14644 and utilities (purified water, WFI, gases) remain qualified.
• Oversee calibration strategy, criteria, frequency and outsourcing.
• Lead Computerized System Validation (CSV) to satisfy 21 CFR Part 11 requirements for quality‑control and manufacturing software.
• Assign tasks to validation SMEs, handle change control, deviation investigations, CAPA and audit management.
• Coordinate with cross‑functional teams to track product lifecycle status and meet country‑specific registration requirements.
• Maintain validation documentation (archiving, retrieval, distribution) and drive continuous improvement, risk management and data‑integrity (ALCOA+) initiatives.
• Support environmental, health and safety compliance per ISO 14001:2015 and company HSE policies.

Required profile

• Result‑oriented with strong accountability and ownership.
• High compliance mindset, diligent, proactive and adaptable.
• Excellent communication, interpersonal and collaboration abilities.
• Demonstrated leadership and people‑management experience.
• Organized, motivated and able to prioritize tasks effectively.

Required skills

• Equipment, facility and utilities qualification (V‑Model, IQ/OQ/PQ).
• ISO‑14644 clean‑room standards.
• Calibration management.
• Computerized System Validation (CSV) and 21 CFR Part 11 compliance.
• Change control, deviation investigation, CAPA and audit management.
• Document management and archiving.
• Risk management and ALCOA+ data‑integrity principles.
• Process, sterilization, cleaning, gowning, visual inspection, aseptic simulation and transport validation.
• ISO 14001:2015 environmental management and HSE compliance.