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.
- Computerized Systems Validation (CSV): Organizing or coordinating the computerized system validation for EMS/BMS, IT infrastructure, Access Control system, Time synchronization and equipment software; ensure data integrity (ALCOA+), audit trails, role based access, and backup/restore testing.
- 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.
- Project Management & Stakeholder Engagement: Create integrated validation schedules, critical path, and resource plans; collaborate with Quality, MSAT, Engineering, EHS, Supply Chain, QC, and IT; communicate status, risks, and escalations.
- Reporting & Handover: Track readiness metrics (qualification completion, operator qualifications); deliver concise reports and handover to routine operations with sustaining plans.
Education, Qualifications, Skills and Experience
- Education: Bachelor’s degree in Pharmacy, Life Sciences, Biotechnology or related field; advanced degree a plus.
- Experience: 8+ years in GMP cell therapy, biologics, or sterile manufacturing; proven track record in site start‑up and validation (facility/equipment/process/CSV). 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: Project management, protocol/report authoring, risk assessment, stakeholder communication, problem solving, and meticulous documentation. Ability to interpret validation data and make sound, patient‑safety‑focused decisions.
- 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: Experience with MES/eBR, EMS/PMS, QMS platforms.
Logistics: Willingness to work on‑site, support off‑hours validation runs, and travel to vendors/CMOs as needed.
Date Posted
04-1月-2026
Closing Date
30-3月-2026
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.