Coordinate qualification of cleanrooms, HVAC, process gases, and PW/PS systems, and ensure environmental monitoring programs are defined and validated
Job Summary
Coordinate qualification of cleanrooms, HVAC, process gases, and PW/PS systems, and ensure environmental monitoring programs are defined and validated.
Plan and witness the IQ/OQ/PQ for critical assets, including communication and coordination with equipment suppliers or third-party validation service providers.
Draft and maintain validation master plan (VMP), protocols, reports, SOPs, and risk assessments, ensuring controlled documentation and readiness for inspections.
Matching Summary
Coordinate qualification of cleanrooms, HVAC, process gases, and PW/PS systems, and ensure environmental monitoring programs are defined and validated.
Skills & Requirements
Must-have
Facility & Utilities Qualification
Equipment Qualification
Aseptic process stimulation
Validation documentation and compliance
Risk management for sterility assurance
Operator qualification for aseptic manipulations
Deviation and CAPA management
Audit and inspection readiness
Nice-to-have
Continuous improvement mindset
High-stakes, inspection-ready environments
Key Requirements
Bachelor’s degree in pharmacy, Life Sciences, Biotechnology or related field
5+ years in GMP cell therapy, biologics, or sterile manufacturing
2+ years of experience as a validation project manager or team manager
Experience with autologous or allogeneic workflows preferred
Familiarity with CFDA GMP, EU GMP (including Annex 1), PIC/S, US FDA guidance
Familiarity with ICH Q7/Q8/Q9/Q10, GAMP 5, ISO 14644, ISPE Baseline Guides