CQV Engineer – Clean-in-Place (CIP) Systems

About the role

The CQV Engineer will lead the engineering, commissioning, qualification and validation of Clean-in-Place (CIP) systems for pharmaceutical and biopharmaceutical manufacturing facilities. You will ensure that CIP solutions meet cGMP, FDA, EU GMP Annex 1 and ISPE standards throughout their lifecycle.

Key responsibilities

• Review CIP system designs, P&IDs, process flow diagrams, equipment layouts and automation sequences.
• Assess cleanability, product-contact surfaces and regulatory compliance of skids, vessels, tanks, bioreactors and fill-finish equipment.
• Perform hydraulic and process evaluations to verify flow, velocity, turbulence and cleaning coverage.
• Support vendor package reviews, Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT).
• Troubleshoot CIP failures, optimise cycles to reduce water, chemical use, cycle time and operating cost.
• Develop and execute commissioning, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and validation protocols.
• Maintain traceability matrices, coordinate punch-list resolution and produce CQV documentation.
• Define cleaning-validation strategies, conduct swab and rinse sampling and analyse validation data.
• Review automation logic, control strategies and sequence of operations to ensure GMP compliance.

Required profile

• Bachelor’s degree in Chemical, Mechanical, Bioprocess, Pharmaceutical or related engineering discipline.
• 5–10 years of engineering experience in the pharmaceutical/biopharmaceutical industry, including at least three years focused on CIP engineering and qualification.
• Hands‑on experience with GMP‑regulated environments such as biologics, vaccines, sterile manufacturing or APIs.
• Proven track record preparing and executing CQV protocols and validation documentation.

Required skills

• CIP system design and P&ID analysis
• Hydraulic and process flow evaluation
• Automation logic and control strategy development
• Commissioning, IQ/OQ/PQ execution
• Validation protocol authoring and reporting
• Cleaning-validation planning and data analysis
• FAT/SAT coordination
• GMP, cGMP, FDA, EU GMP Annex 1 and ISPE compliance

What we offer

• Competitive monthly salary (SGD 7,000–10,000)
• Opportunity to work on cutting‑edge pharmaceutical projects across Singapore
• Professional development in a regulated manufacturing environment