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
applicant@tstar-recruit.com.sg
We regret that only shortlisted candidates will be notified
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