Coordinate qualification of cleanrooms, HVAC, process gases, and PW/PS systems, ensuring environmental monitoring programs are defined and validated
Job Summary
Coordinate qualification of cleanrooms, HVAC, process gases, and PW/PS systems, ensuring environmental monitoring programs are defined and validated.
Plan and witness IQ/OQ/PQ for critical assets, including communication with equipment suppliers or third-party validation service providers.
Prepare the site for internal audits and health authority/customer inspections regarding validation, providing evidence packages and driving closure of findings.
Matching Summary
Coordinate qualification of cleanrooms, HVAC, process gases, and PW/PS systems, ensuring environmental monitoring programs are defined and validated.
Skills & Requirements
Must-have
Facility & Utilities Qualification
Equipment Qualification IQ/OQ/PQ
Aseptic process stimulation
Validation documentation and compliance
Risk management for sterility assurance
Operator qualification for aseptic manipulations
Deviation/CAPA and Change Control management
Nice-to-have
Continuous improvement mindset
Collaboration and ownership
High-stakes, inspection-ready environments
Key Requirements
5+ years in GMP cell therapy, biologics, or sterile manufacturing
2+ years as validation project manager or team manager
Bachelor’s degree in pharmacy, Life Sciences, Biotechnology or related field