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