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:
  
  
  
  1. Manufacturing equipment and production lines
  
  
  2. Critical utilities (PW, WFI, HVAC, compressed gases, nitrogen)
  
  
  3. Cleanrooms in compliance with ISO 14644
  
  
  4. Sterile and non‑sterile manufacturing facilities
  
  
  
  


• Hands‑on experience in:
  
  
  
  1. Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)
  
  
  2. Re‑qualification and periodic review programs
  
  
  3. FAT and SAT execution and documentation
  
  
  
  


• Strong experience in:
  
  
  
  1. Process validation, cleaning validation, sterilization validation, and aseptic process simulation (media fills)
  
  
  2. 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