全职 CQV Engineer 工作, 薪水, Antaes Asia 公司招聘中 - Ricebowl

CQV Engineer – Consultant position

Job Description:

• Contribute to Life Science projects for Antaes Asia clients
• Act as a core reviewer for CQV documentation and processes, ensuring all qualification activities are thoroughly evaluated and approved.
• Develop and execute CQV documentation including commissioning protocols, FAT/SAT reports, IQ/OQ/PQ protocols, summary reports, and traceability matrices.
• Support end-to-end CQV lifecycle for process, utility, and support systems e.g. bioreactors, chromatography skids, filtration units, CIP/SIP, WFI, HVAC, autoclaves, and clean utilities.
• Participate in design reviews (URS, FDS, P&ID walkdowns) to ensure CQV considerations are integrated during project design and construction.
• Manage execution of commissioning and qualification activities in alignment with project schedules, safety standards, and GMP compliance.
• Support automation qualification (DeltaV, PLC, SCADA) and ensure integration with process control systems.
• Review vendor documentation and coordinate FAT and SAT with suppliers and engineering teams.
• Troubleshoot and resolve technical issues encountered during CQV execution.
• Ensure all CQV deliverables meet internal Quality and Validation standards, and align with site Validation Master Plan (VMP).
• Contribute to the promotion of Antaes services on top of assistance provided to clients

Job Requirements:

• Bachelor’s Degree in Chemical, Mechanical, Biomedical, or related Engineering field.
• At least 3 years of CQV experience in the pharmaceutical industry, with specialized expertise in VS and QC Equipment / HVAC qualification alongside Computer System Validation (CSV) experience.
• Must possess validation experience driven by a strict Quality mindset, or otherwise have direct QA validation experience.
• Experience with other performance qualifications such as cleaning qualification or Single-Use Material (SUM) qualification would be a strong plus point.
• Strong understanding of GMP, GEP, ISPE Baseline Guides, ASTM E2500, and FDA/EMA validation expectations.
• Experience in process equipment qualification (bioreactors, chromatography, UF/DF, CIP/SIP), clean utilities, and automation integration.
• Familiar with risk-based CQV approach and change control processes.
• Proficiency with documentation management systems (e.g., Veeva).
• Candidate must be highly motivated, be able to work independently as well as in a team and have good organizational and oral and written communication skills.
• Excellent communication skills, both written and verbal, in English.