Major responsibilities

• Facility & Utilities Qualification (URS/DQ/IQ/OQ/PQ): Coordinate qualification of cleanrooms (ISO classes), HVAC, process gases, and PW/PS systems; ensure environmental monitoring programs are defined and validated.
• Equipment Qualification: Plan and witness the IQ/OQ/PQ for critical assets (biosafety cabinets, incubators, centrifuges, isolator, cryogenic freezers, liquid nitrogen storage, autoclave, QC instruments), including communication and coordination with equipment suppliers or third-party validation service providers.
• Aseptic process stimulation: Organizing or coordinating aseptic process simulation.
• Third-party Validation Service: Responsible for reviewing validation or qualification protocols provided by suppliers, assisting and supervising the implementation of supplier protocols, and promptly reporting any problems discovered during implementation;
• Documentation & Compliance: Draft and maintain validation master plan (VMP), protocols, reports, SOPs, and risk assessments (FMEA); ensure controlled documentation, versioning, and readiness for inspections.
• Risk Management: Conduct and maintain risk registers for sterility assurance, cross‑contamination, and patient safety; implement mitigations and monitor effectiveness.
• Training & Qualification: Coordinate operator qualification for aseptic manipulations and critical steps; ensure ongoing competency assessments and deviation/error reduction initiatives.
• Deviation/CAPA & Change Control: Lead or support investigations for validation‑related deviations; define robust CAPAs; manage changes to facilities/equipment/processes/software with impact assessments.
• Audit & Inspection Readiness: As the validation SME to prepare the site for internal audits and health authority/customer inspections regarding to the validation; provide evidence packages, walkthroughs, and responses; drive closure of findings.

Education, Qualifications, Skills and Experience

• Education: Bachelor’s degree in pharmacy, Life Sciences, Biotechnology or related field; advanced degree a plus.
• Experience: 5+ years in GMP cell therapy, biologics, or sterile manufacturing; proven track record in site start‑up and validation (facility/equipment/process); 2+ years of experience as a validation project manager or team manager and having led qualification work; Experience with autologous or allogeneic workflows preferred.
• Technical Knowledge: Strong understanding of qualification and validation strategy, aseptic processing, contamination control, EM programs, sterility assurance, closed‑system operations, single‑use technologies.
• Regulations & Standards: Familiarity with CFDA GMP, EU GMP (including Annex 1), PIC/S, US FDA guidance (cell therapy, CGMP), ICH Q7/Q8/Q9/Q10, GAMP 5, ISO 14644, ISPE Baseline Guides, and data integrity (ALCOA+).
• Skills: Familiar with the use of qualification instruments such as temperature verification instrument, pure steam mass tester, particle counter.
• Behavioral Attributes: Ownership, urgency, collaboration, and a continuous improvement mindset; comfortable working in high‑stakes, inspection‑ready environments.

Preferred/Optional

• Certifications: PMP, Lean Six Sigma, or GAMP qualifications.
• Tools: Proficient in using Microsoft Office software such as Word, Excel, and PowerPoint;
• Logistics: Willingness to work on‑site, support off‑hours validation runs, and travel to vendors/CMOs as needed.