Lead MS&T Validation Engineer

About the role

Lead the Manufacturing Science & Technology (MS&T) validation activities across commercial manufacturing, technology transfer and site readiness, acting as the technical bridge between R&D, production, quality and engineering.

Key responsibilities

• Develop, review, approve and manage validation master plans, schedules and documentation in compliance with GMP and data integrity requirements.
• Lead the full validation lifecycle using the V‑Model (URS, FAT, SAT, IQ, OQ, PQ, re‑qualification) for equipment, utilities, CSV systems and processes.
• Ensure critical utilities (PW, WFI, HVAC, compressed gases, nitrogen) remain validated and cleanroom qualification meets ISO‑14644 standards.
• Prepare and evaluate URS, support procurement, CAPEX and technical quotation assessments.
• Conduct investigations of process deviations, OOS/OOT results, perform root‑cause analysis and propose CAPAs.
• Oversee cleaning, sterilization, transport, aseptic media‑fill and gowning qualification programs.
• Collaborate with QA, procurement and site teams for equipment procurement and validation activities.

Required profile

• Bachelor’s degree in pharmacy, chemical, mechanical, electrical or industrial engineering (master’s degree advantageous).
• 6–10 years of experience in GMP‑regulated pharmaceutical manufacturing with extensive hands‑on qualification and validation work.
• Strong accountability, result‑orientation and ability to manage workload and adapt to changing priorities.
• Excellent communication and collaboration skills, with a focus on compliance and continuous improvement.

Required skills

• GMP and ISO‑14644 compliance
• Validation master planning, V‑Model execution (URS, FAT, SAT, IQ, OQ, PQ, re‑qualification)
• Equipment, utilities and CSV system qualification
• Cleaning, sterilization, transport and aseptic process (media‑fill) validation
• Root‑cause analysis and statistical tools
• CAPA development and process improvement
• MS&T coordination with R&D, production, QA and engineering