CQV / COMMISSIONING ENGINEER

Your tasks

ROLE PURPOSE We are seeking experienced CQV / Commissioning Engineers to support the commissioning and qualification of process equipment, packaged equipment and process skids for a pharmaceutical manufacturing facility at GSK Tuas.

The role is primarily site execution focused, supporting equipment from Mechanical Completion and Site Acceptance Testing (SAT) through equipment shakedown, commissioning, I/O verification and Installation/Operational Qualification (IOQ).

The successful candidate will work closely with Engineering, CQV, Automation, QA, Operations, Maintenance, equipment vendors and contractors to ensure systems are safely commissioned, tested, qualified and ready for operational handover.

1. Mechanical Completion & System Readiness

• Support Mechanical Completion (MC) inspections and system walkdowns.
• Verify installed equipment against approved P&IDs, equipment layouts, specifications, datasheets and vendor documentation.
• Check completeness of process piping, valves, instruments, electrical connections, utilities and equipment interfaces.
• Verify equipment installation, tagging, calibration status and documentation readiness.
• Identify and record installation defects, outstanding works and punch-list items.
• Coordinate punch-list rectification and closure prior to commissioning activities.
• Confirm system readiness before energisation, start-up and functional testing.

2. Site Acceptance Testing – SAT

• Prepare for, support and execute Site Acceptance Testing (SAT) for process equipment and vendor skids.
• Review approved SAT protocols, vendor test procedures and acceptance criteria before execution.
• Witness and document functional testing of equipment and skid components.
• Verify equipment functionality following transportation, installation and connection at site.
• Coordinate SAT activities with OEMs, equipment vendors, Engineering, Automation and CQV teams.
• Record test results, discrepancies and deviations and follow through to satisfactory closure.

3. Process Equipment / Skid Shakedown Perform hands-on equipment and process skid shakedown activities including, where applicable:

• Equipment initial start-up and functional checks.
• Pumps, motors, agitators and rotating equipment checks.
• Valve operation and valve-position verification.
• Instrument functionality checks.
• Utility availability and equipment utility-interface checks.
• Dry runs / water runs as applicable.
• Leak and connection checks.
• Equipment operating sequence verification.
• Start / stop sequence testing.
• Alarm verification.
• Interlock and permissive testing.
• Equipment trip and fail-safe testing.
• Emergency-stop functionality.
• Process sequence and control-function verification.

Identify equipment, mechanical, electrical, instrumentation, automation or control issues during shakedown and coordinate troubleshooting with the relevant discipline or vendor.

4. I/O Checks & Automation Interface

• Support execution of I/O checks, loop checks and functional verification between field instruments/equipment and the control system.
• Verify digital and analogue input/output signals.
• Verify instrument ranges, engineering units and status indication.
• Verify valve open/close commands and feedback.
• Verify motor start/stop commands and running/trip feedback.
• Test equipment alarms, trips, interlocks and permissives.
• Support verification of control sequences and equipment automation functionality.
• Work closely with Automation / PCS / PLC / SCADA teams to troubleshoot I/O and functional issues.

5. Commissioning Execution

• Execute commissioning activities according to approved commissioning plans and procedures.
• Support equipment energisation and Safe-to-Start readiness.
• Coordinate commissioning activities between equipment vendors, Engineering, E&I, Automation, Operations and CQV teams.
• Troubleshoot technical issues encountered during equipment commissioning.
• Ensure all commissioning test records and supporting evidence are properly completed.
• Maintain equipment commissioning status and outstanding-action tracking.
• Ensure commissioning activities comply with applicable site safety, GMP and Good Engineering Practice requirements.

6. CQV / IOQ Execution

• Review and execute approved Installation and Operational Qualification (IOQ) protocols.
• Verify installation against approved design documentation and manufacturer requirements.
• Verify critical instruments and equipment calibration status.
• Execute operational and functional testing against predefined acceptance criteria.
• Verify alarms, interlocks, operating sequences, operating ranges and critical equipment functions.
• Record qualification results accurately and contemporaneously.
• Raise and document discrepancies / deviations encountered during execution.
• Support investigation, technical assessment, corrective action and retesting where required.
• Ensure all protocol test steps, attachments and supporting evidence are complete before submission for review.

7. CQV Documentation Support preparation, review and/or execution of documentation including:

• FAT / SAT protocols and reports
• Commissioning protocols and test sheets
• Mechanical Completion records
• Equipment and system walkdown records
• Punch lists
• I/O and loop-check records
• IOQ protocols and reports
• Test scripts
• Deviation / discrepancy records
• Traceability documentation
• Calibration certificates
• Vendor turnover documentation
• Equipment manuals and technical documentation
• As-built drawings and P&IDs
• Commissioning / qualification turnover packages

Ensure documentation is completed in accordance with Good Documentation Practice (GDP), data-integrity requirements and applicable site procedures.

8. Vendor & Cross-Functional Coordination

• Coordinate directly with process-equipment and skid vendors during installation, SAT, commissioning and qualification.
• Work closely with Engineering, Construction, CQV, Automation, QA, Operations, Maintenance and EHS teams.
• Participate in equipment walkdowns, commissioning meetings and daily coordination meetings.
• Escalate technical constraints, deviations and schedule risks promptly.
• Coordinate vendor troubleshooting and corrective works.
• Support system handover from Project / CQV to Operations and Maintenance.

9. Safety & GMP Compliance

• Perform all commissioning activities in accordance with site EHS requirements.
• Comply with Permit-to-Work, LOTO and equipment energisation requirements.
• Ensure equipment is safe and ready prior to energisation or dynamic testing.
• Maintain appropriate control of live systems during commissioning.
• Follow applicable cGMP, GDP, GEP and data-integrity requirements.
• Maintain clear and complete commissioning and qualification records suitable for quality review and audit.

PRIMARY PROJECT DELIVERABLE Successful completion and documented handover of assigned process equipment / skids through:

Mechanical Completion → SAT → Equipment Shakedown → Commissioning → I/O & Functional Checks → IOQ → Punch / Deviation Closure → Qualified System Handover

The position is intended for personnel who are capable of both field execution and CQV documentation, rather than a documentation-only validation role.

Requirements

Education Diploma or Degree in one of the following or a related discipline:

• Chemical Engineering
• Mechanical Engineering
• Process Engineering
• Electrical / Electronic Engineering
• Instrumentation & Control Engineering
• Pharmaceutical / Biotechnology Engineering

• Approximately 3–8+ years of relevant experience in commissioning, qualification or validation within Pharmaceutical, Biotechnology, Life Sciences or other highly regulated process industries.
• Hands-on experience with process equipment and/or packaged process skids is strongly preferred.
• Practical experience executing SAT, commissioning, equipment shakedown and IQ/OQ or IOQ activities.
• Experience supporting equipment from Mechanical Completion through commissioning and qualification is highly desirable.
• Previous pharmaceutical / biopharmaceutical project or manufacturing-site experience is preferred.

TECHNICAL COMPETENCIES Candidates should be able to understand and work with:

• P&IDs
• Equipment layouts / GA drawings
• Equipment datasheets
• Process Flow Diagrams
• Instrument lists
• I/O lists
• Cause & Effect matrices
• Control narratives
• Functional / Design Specifications
• Vendor manuals
• Equipment specifications
• Commissioning procedures
• SAT protocols
• IQ/OQ / IOQ protocols

Knowledge or experience with the following would be advantageous:

• PLC / SCADA / Process Control Systems
• Automated process equipment
• Pumps and rotating equipment
• Control valves and instrumentation
• CIP / SIP systems
• Process vessels and tanks
• Filtration systems
• Heat exchangers
• Dosing / transfer systems
• Packaged process skids
• Clean utilities and process-utility interfaces

GMP / CQV KNOWLEDGE Good working knowledge of pharmaceutical engineering and qualification concepts including:

• cGMP
• Good Engineering Practice (GEP)
• Good Documentation Practice (GDP)
• Data Integrity / ALCOA+ principles
• Commissioning & Qualification lifecycle
• FAT / SAT
• IQ / OQ / IOQ
• Risk-based qualification principles
• ISPE Commissioning & Qualification concepts
• ASTM E2500 principles

Familiarity with GAMP 5 principles for automated or computerised equipment would be an advantage.

The successful candidate should be

• Hands-on and comfortable working directly with equipment at site.
• Technically strong with good troubleshooting ability.
• Able to work independently during commissioning and protocol execution.
• Detail-oriented with strong documentation discipline.
• Comfortable coordinating with OEMs and equipment vendors.
• Able to communicate effectively with Engineering, Automation, QA and Operations teams.
• Able to manage multiple equipment packages and priorities in a fast-paced project environment.
• Safety conscious and familiar with commissioning activities involving energised / live systems.
• Able to identify problems, propose solutions and drive issues through to closure.

Other

CQV / COMMISSIONING ENGINEER · Process Equipment & Skids *Project / Client Site: GSK Plant, Tuas, Singapore Industry: Pharmaceutical / Biopharmaceutical Manufacturing Function: Commissioning, Qualification & Validation (CQV) Employment Type:** Project / Contract Assignment