cqv
3 weeks ago
About the Role
We are seeking a CQV Engineer to support commissioning, qualification, and validation activities for a pharmaceutical manufacturing facility in Singapore. The role involves ensuring compliance with GMP standards and regulatory requirements while executing validation protocols.
Key Responsibilities- Develop and execute CQV protocols (IQ/OQ/PQ) for equipment, utilities, and automation systems.
- Perform commissioning and qualification of process equipment and clean utilities (e.g., HVAC, WFI, clean steam).
- Support validation lifecycle activities, including risk assessments, protocol execution, and reporting.
- Work with engineering, production, automation, and quality teams to coordinate CQV activities.
- Investigate and resolve validation deviations while ensuring compliance with GMP, FDA, and EU regulations.
- Maintain validation documentation, including SOPs and change controls.
- Provide technical support during regulatory audits and inspections.
- Degree in Engineering (Mechanical, Chemical, Electrical, or related field).
- 3-7 years of CQV experience in pharmaceutical or biotech manufacturing.
- Knowledge of GMP, FDA 21 CFR Part 11, ISPE Baseline Guides, and ASTM E2500.
- Experience with IQ/OQ/PQ execution and clean utility validation.
- Strong problem-solving skills and ability to work with cross-functional teams.
- Experience in biopharma, sterile manufacturing, or API production.
- Familiarity with Annex 15, GAMP 5, and risk-based validation approaches.
- Background in brownfield projects or facility expansions.
FDA
Chromatography
GMP
GAMP
HVAC
Electrical
Protocol
Biotechnology
Compliance
Audits
Regulatory Requirements
Life Sciences
API
Manufacturing
Commissioning
Technical Support
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