CQV Engineer

ANTAES ASIA PTE. LTD.; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A life sciences consultancy in Singapore is seeking a qualified individual to contribute to CQV projects for pharmaceutical clients. Key responsibilities include developing CQV documentation, supporting lifecycle processes, and managing project execution in compliance with GMP standards. Candidates should have a Bachelor's in Engineering and 3–7 years of experience in CQV, along with excellent communication skills in English. This role offers a dynamic and collaborative environment.

Qualifications

• 3–7 years of CQV experience in the pharmaceutical industry.
• Strong understanding of GMP, GEP, ISPE Baseline Guides, ASTM E2500, and FDA/EMA validation expectations.
• Experience in process equipment qualification, clean utilities, and automation integration.
• Familiar with risk‑based CQV approach and change control processes.
• Excellent communication skills, both written and verbal, in English.

Responsibilities

• Contribute to Life Science projects for clients.
• Develop and execute CQV documentation including various protocols and reports.
• Support end-to-end CQV lifecycle for critical systems.
• Manage commissioning and qualification activities safely and compliantly.
• Support automation qualification and integrate with process control systems.
• Review vendor documentation related to CQV.

Skills

Pharmaceutical Industry

Chromatography

GMP

HVAC

Traceability

PLC

Written Communication

SCADA

Equipment Qualification

Filtration

Change Control

Process Control

Manufacturing

Commissioning

Able To Work Independently

Education

Bachelor’s Degree in Chemical, Mechanical, Biomedical, or related Engineering field

Tools

Veeva

Job description

Job Description

• Contribute to Life Science projects for Antaes Asia clients
• 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).
• Support handover of qualified systems to Manufacturing and Maintenance teams, including training and documentation.
• Collaborate closely with cross‑functional teams including Engineering, QA Validation, Manufacturing, and Automation.
• 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.
• 3–7 years of CQV experience in the pharmaceutical industry
• 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, 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 – to communicate and work with English speaking counterparts

Skills

• Pharmaceutical Industry
• Chromatography
• GMP
• HVAC
• Traceability
• PLC
• Written Communication
• SCADA
• Equipment Qualification
• Filtration
• Change Control
• Process Control
• Manufacturing
• Commissioning
• Able To Work Independently

Engineere • D01 Cecil, Marina, People’s Park, Raffles Place, SG