Lead-MSAT (Validation)

Detailed Job Description:

• Lead MS&T activities supporting commercial manufacturing, technology transfer, and site readiness.
• Act as the technical bridge between R&D, Technology Transfer, Production, Quality, and Engineering.
• Prepare, review, approve, archive, retrieve, and distribute validation documents.
• Ensure compliance with GMP documentation and data integrity requirements.
• Maintain validation master plans and validation schedules.
• Ensure robust scientific understanding and control of manufacturing processes across the product lifecycle.
• Support in writing the URS (user requirement specifications) for Project activities, ensuring all assets has URSs before entering the Purchasing Cycle
• Follow-up with procurement and CAPEX manager
• Support in preparation the technical evaluation of quotations from different vendors
• Co-ordinate with procurement, MS&T, QA in RAK site for any similar equipment procurement
• Lead and execute the validation lifecycle using the V‑Model approach (URS, FAT, SAT, IQ, OQ, PQ, re‑qualification).
• Ensure all critical utilities (PW, WFI, HVAC, compressed gases, nitrogen) remain in a validated state.
• Ensure cleanroom qualification activities comply with ISO‑14644 requirements.
• Review and approve validation protocols, reports, and risk assessments.
• Lead or support investigations related to process deviations, OOS, OOT, and atypical results.
• Perform root cause analysis using scientific and statistical tools.
• Propose technically sound CAPAs and process improvements.
• Support batch disposition decisions from a technical perspective.
• Partner in FAT, SAT, DQ, IQ, OQ, PQ for equipment, CSV, systems (Water, utilities, HVAC, electricity, Thermal mapping).
• Lead process validation activities for new and existing products.
• Execute and oversee cleaning validation, sterilization validation, and transport validation.
• Lead aseptic process simulation (media fills) and gowning qualification programs.
• Support visual inspection qualification activities where applicable.

Core Competency:

• In terms of competency, you are highly result-oriented with an intense sense of accountability & ownership.
• High compliance adherence, having strong diligence, initiative-taking, and flexibility.
• Excellent communication, interpersonal, and collaboration skills.
• Must be able to manage tasks, plan workload effectively, prioritize, and easily adapt to changing situations.
• Contribute to EHS activities, audits, and continual improvement initiatives.

Qualification/Functional Knowledge:

• Bachelor’s degree in pharmacy, Chemical Engineering, Mechanical Engineering, Electrical Engineering, Industrial Engineering, or related scientific discipline
  (master’s degree in pharmacy / engineering is an advantage)
• Minimum 6–10 years of experience in pharmaceutical manufacturing within GMP‑regulated environments, with extensive hands‑on experience in qualification and validation activities
• Strong and practical knowledge of:
• cGMP, SFDA, WHO, EU GMP, and ICH guidelines
• Qualification and validation lifecycle using the V‑Model approach
• GMP documentation practices and regulatory inspection expectations
• Proven experience in validation of:
  • Manufacturing equipment and production lines

  • Critical utilities (PW, WFI, HVAC, compressed gases, nitrogen)

  • Cleanrooms in compliance with ISO 14644

  • Sterile and non‑sterile manufacturing facilities
• Hands‑on experience in:
  • Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)

  • Re‑qualification and periodic review programs

  • FAT and SAT execution and documentation
• Strong experience in:
  • Process validation, cleaning validation, sterilization validation, and aseptic process simulation (media fills)

  • Gowning qualification, visual inspection qualification, and transport validation
• Practical knowledge of calibration systems, including rationale, acceptance criteria, frequency setting, and outsourced calibration management
• Solid experience in Computerized System Validation (CSV):
• Validation of manufacturing, utilities, QC, and validation systems
• Compliance with 21 CFR Part 11 and data integrity (ALCOA+) principles
• Strong experience in EQMS activities, including:
• Change Control impact assessments
• Deviation investigations and root cause analysis
• CAPA development and effectiveness checks
• Audit support and regulatory inspection readiness
• Experience acting as validation SME during internal, customer, and regulatory audits, including SFDA inspections
• Strong leadership and team‑coordination skills with experience assigning and reviewing work of validation engineers and SMEs
• Excellent analytical, problem‑solving, and risk‑assessment skills
• Proficiency in MS Office and electronic QMS / validation management system