Clean Utilities CQV Engineer (Pharma) (SG)
Date Posted: August 12, 2024
Job Description
We are seeking a skilled Clean Utilities CQV Engineer to join our pharmaceutical project team in Singapore. In this role, you will be responsible for commissioning, qualification, and validation (CQV) of clean utility systems, ensuring that all processes meet stringent regulatory and quality standards. Your expertise will be pivotal in the successful delivery of this high-profile project.
Key Responsibilities
- Lead the commissioning, qualification, and validation activities for clean utility systems, including water for injection (WFI), purified water, clean steam, and compressed gases.
- Develop and execute IQ, OQ, and PQ protocols for clean utility systems, ensuring compliance with GMP and other regulatory requirements.
- Collaborate with cross-functional teams, including engineering, quality, and operations, to ensure seamless integration of clean utility systems into the overall project.
- Review and approve design specifications, vendor documentation, and test plans related to clean utility systems.
- Perform risk assessments and gap analyses to identify and mitigate potential compliance issues.
- Ensure that all CQV documentation is accurate, complete, and meets internal and external audit requirements.
- Provide technical support during system troubleshooting and deviation investigations to ensure timely resolution.
- Participate in project meetings, providing updates on CQV activities and ensuring alignment with project timelines.
- Maintain up-to-date knowledge of industry best practices and regulatory changes related to clean utility systems.
Required Qualifications and Skills
- Bachelor’s degree in Engineering, Chemical Engineering, or a related field.
- Several years of experience in CQV activities, specifically with clean utility systems in the pharmaceutical or biotechnology industry.
- Strong knowledge of GMP regulations, clean utility system design, and validation principles.
- Proficiency in developing and executing IQ, OQ, and PQ protocols.
- Excellent problem-solving and analytical skills.
- Ability to work collaboratively in a cross-functional team environment.
- Strong documentation and communication skills.
If you are keen to grow your career with this job, apply with us and send us your resume now. All shortlisted candidates will be contacted shortly.
Reference no.: 122-4948-2918-NW
Registration no.: 968446516E
