CQV Engineer

Our esteemed client, an established MNC, is searching for a CQV Engineer:

Job Responsibilities:

• Plan, execute, and manage Commissioning, Qualification, and Validation (CQV) activities for pharmaceutical and biotechnology manufacturing facilities, utilities, and process equipment.

• Develop, review, and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports in accordance with GMP, GAMP 5, and internal procedures.

• Collaborate closely with engineering, project management, and quality assurance teams to ensure timely and successful execution of CQV activities.

• Identify, troubleshoot, and resolve technical and validation-related issues throughout project execution.

• Ensure all commissioning and validation activities comply with applicable regulatory requirements, including FDA, EMA, PIC/S, and local health authority guidelines.

• Support Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and risk assessments for new or modified systems and equipment.

• Provide technical expertise and recommendations during project design, construction, commissioning, and operational readiness stages.

• Prepare and maintain accurate CQV documentation, test records, and validation reports to support regulatory compliance.

• Support the successful start-up and operational readiness of pharmaceutical and biotechnology manufacturing facilities for commercial production.

Job Requirements:

• Bachelor's Degree in Engineering, Life Sciences, or a related discipline.
• Minimum 2–5 years of relevant experience in commissioning, qualification, and validation within the pharmaceutical or biotechnology industry.
• Candidates with 5 or more years of relevant experience may be considered for senior positions.
• Good knowledge of Good Manufacturing Practices (GMP), GAMP 5, ISPE Baseline Guides, and applicable pharmaceutical regulatory requirements.
• Familiarity with CQV methodologies, including IQ, OQ, PQ, FAT, and SAT.
• Hands-on experience with pharmaceutical utility systems, such as Water for Injection (WFI), clean steam, and HVAC systems, will be an advantage.
• Experience in process equipment qualification or cleanroom validation is preferred.
• Strong analytical, troubleshooting, and problem-solving skills.
• Good communication, interpersonal, and project coordination skills.
• Ability to work independently and collaborate effectively with cross-functional teams in a regulated manufacturing environment.

Additional Information:

• Salary: Salary up to SGD 7,000 + AWS + Bonus (1-2months)
• Working Location: Islandwide, Singapore
• Working Hours: 5 days' Work Week

For interested parties, kindly click on "APPLY NOW" or send in your resume in MS Word format to

[email protected]

We regret that only shortlisted candidates will be notified

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