Kerja Sepenuh Masa CQV Engineer, Gaji tinggi SGD 8,000 di ANTAES ASIA PTE. LTD. - Maukerja

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.

Created in 2007 in Switzerland, Antaes is a consulting company, specialized in Information Systems and Organization.

Antaes is operating in Singapore since 2016 to initially accompany customers of the Financial Services industry. Our Financial Services team is a diverse consulting team, many recruited from the industry, combining in-depth knowledge of our clients’ businesses, technology, and consulting disciplines. We are providing our financial industry clients with Business Management & Information Systems services.

At Antaes Asia, we help our customers with:

• Business and IT Model transformation
• Legal & compliance
• Enhancement of client experience
• IT engineering

Antaes places people at the heart of the strategy, with a view to building loyalty and trust with our consultants and our partners. The talented people who join our teams are focused, empathic, responsive, driven, and resolutely turned toward new ideas.

Buidling on the same approach and thanks to expertise gained at the group level, Antaes Asia is now also active in other industries such as TelCo, Shipping, LifeSciences...