C&Q Engineer

Job Purpose

To lead and execute Commissioning, Qualification, and Validation (CQV) activities for new and upgraded pharmaceutical manufacturing equipment and systems, ensuring compliance with GMP, FDA, EMA, and Singapore Health Sciences Authority (HSA) requirements.

(experience level - deltaV operations experience, commission of new equipment (tanks/ bioreactors etc), pharma manufacturing equipment (tanks, chrom column, ultra filtration etc, minimum 2 years relevant experience)

1. C&Q Execution

Develop and review C&Q documentation: Commissioning Plans, FAT/SAT protocols, IQ/OQ/PQ protocols, and summary reports.

Execute commissioning and qualification of pharma process equipment: bioreactors, fermenters, chromatography columns, ultrafiltration/diafiltration (UF/DF) systems, buffer/media preparation tanks, and CIP/SIP systems.

Lead deltaV automation system operational testing, including loop checks, HMI/SCADA verification, and alarm/sequence testing.

2. Project Support

Coordinate with engineering, manufacturing, and quality teams to ensure timely handover of qualified systems.

Troubleshoot equipment and automation issues during commissioning and startup phases.

Support change controls, deviations, and risk assessments (FMEA) related to equipment qualification.

3. Compliance & Safety

Ensure all activities follow cGMP, SOPs, and safety guidelines.

Participate in internal and regulatory audits as a C&Q subject matter expert.

Maintain documentation in compliance with GDP (Good Documentation Practices).

• Minimum 2 years hands-on C&Q experience in pharmaceutical or biotech facilities.

• Direct experience with deltaV automation systems - configuration, testing, and operations.

• Hands-on commissioning of bioreactors, process tanks, chromatography systems, and filtration skids.

• Knowledge of GMP compliance and validation lifecycle (URS, DQ, IQ, OQ, PQ).

• (experience level - deltaV operations experience, commission of new equipment (tanks/ bioreactors etc), pharma manufacturing equipment (tanks, chrom column, ultra filtration etc, minimum 2 years relevant experience)

• Must available immediately

• 6 Months contract (Rolling contract)