Project CQV Lead-Execution- BioPharma

EFOR (formerly Process Engineering Specialists); Singapore; On-site; SGD 120,000 - 170,000; Full time

Job summary

PES International in Singapore is seeking a Project CQV Lead to drive commissioning and qualification activities across life sciences projects. You will manage systems from Mechanical Completion through Handover, coordinating with EPCM teams, vendors and SMEs to ensure schedule adherence and compliant delivery.

The role requires hands-on experience with FAT, pre-FAT, LOTO, RAMS, PSSR and instrument and software integration with DCS/PLC.

Qualifications

• CQV activities executed in accordance with GMP, GDP, ALCOA+ and EHS requirements.
• Experience coordinating commissioning across lifecycle stages (Mechanical Completion to Handover).
• Ability to work with cross-functional teams including EPCM, vendors and SMEs.

Responsibilities

• Execute CQV activities in compliance with approved execution plans, GMP, Global SOPs, GDP, ALCOA+ and EHS requirements.
• Manage assigned systems from Mechanical Completion (A1) through Commissioning Completion (A2) to Handover (H0).
• Support FAT, pre-FAT inspections, Mechanical Completion walkdowns, SAT and vendor commissioning activities.
• Prepare and execute commissioning activities, including LOTO, RAMS, PSSR and Permit to Work.
• Coordinate system start-up, energization, calibration, utility commissioning, balancing and equipment testing.
• Execute commissioning and shakedown testing of control loops, alarms, interlocks, operational sequences and equipment performance.
• Commission and troubleshoot process and utility systems integrated with DCS and PLC control systems.
• Execute IV, OV, PQ and cycle development protocols using digital validation platforms, ensuring accurate documentation.
• Coordinate with EPCM teams, vendors and SMEs to resolve technical issues and maintain project schedules.
• Manage deficiencies, punch lists, remediation, protocol updates and closeout documentation to ensure successful handover.

Job description

PES is an international services company providing Project Management, Construction Management, Commissioning & Qualification and Automation services to our clients in the pharmaceutical, nutritional and related sectors.

With offices across Europe, Asia and US, our core focus is on consistently delivering high quality outcomes for our multinational clients.

This focus, and our people's experience in delivering consistent quality results for our clients over the past 20 years has been key to our success to date.

We are currently looking for Project CQV Lead to join us on a permanent basis to help us deliver various projects in the Life Sciences Industry.

Key Attributes/Responsibilities:

• Execute CQV activities in compliance with approved execution plans, GMP, Global SOPs, GDP, ALCOA+ and EHS requirements.
• Manage assigned systems from Mechanical Completion (A1) through Commissioning Completion (A2) to Handover (H0).
• Support FAT, pre-FAT inspections, Mechanical Completion walkdowns, SAT and vendor commissioning activities.
• Prepare and execute commissioning activities, including LOTO, RAMS, PSSR, Method Statements and Permit to Work.
• Coordinate system start-up, energization, calibration, utility commissioning, balancing and equipment testing.
• Execute commissioning and shakedown testing of control loops, alarms, interlocks, operational sequences and equipment performance.
• Commission and troubleshoot process and utility systems integrated with DCS and PLC control systems.
• Execute IV, OV, PQ and cycle development protocols using digital validation platforms, ensuring accurate documentation.
• Coordinate with EPCM teams, vendors and SMEs to resolve technical issues, manage deviations and maintain project schedules.
• Manage deficiencies, punch lists, remediation, protocol updates and closeout documentation to ensure successful system handover.

PES International operates as an equal-opportunity employer. No terminology in this advert is intended to discriminate on the grounds of age, race, religion, sexual orientation or any other factors with no bearing to employment skills. We confirm that we are happy to accept applications from persons of any background for this role.