Back to jobsBachelor’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:
Hands‑on experience in:
Strong experience in:
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
Job Description
(master’s degree in pharmacy / engineering is an advantage)
- 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
- Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)
- Re‑qualification and periodic review programs
- FAT and SAT execution and documentation
- Process validation, cleaning validation, sterilization validation, and aseptic process simulation (media fills)
- Gowning qualification, visual inspection qualification, and transport validation