Process Equipment & Skids
Project / Client Site:
GSK Plant, Tuas, Singapore
Industry:
Pharmaceutical / Biopharmaceutical Manufacturing
Function:
Commissioning, Qualification & Validation (CQV)
Employment Type:
Project / Contract Assignment
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.
KEY RESPONSIBILITIES
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.
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
Experience
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.
PERSONAL ATTRIBUTES
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.
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.
At Regional Energy, we don’t just fill roles—we build the teams that build the future. We are the driving force behind Southeast Asia's most ambitious and complex industrial, energy, and infrastructure projects. Our mission is to provide the elite Project Management Office (PMO) leadership that guarantees project certainty and success, from conception to completion.
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