CQV Engineer

COALESCE MANAGEMENT CONSULTING PTE. LIMITED; Singapore; On-site; SGD 78,000 - 134,000; Full time

Job summary

COALESCE MANAGEMENT CONSULTING PTE. LIMITED is seeking a CQV Engineer to plan, execute, and document commissioning and qualification activities for pharmaceutical process equipment, including temperature-controlled units, in a GMP environment.

The role involves close coordination with Engineering, Quality, Operations, Automation, Metrology, and vendors to deliver inspection-ready validation packages. The ideal candidate holds a engineering degree and hands-on CQV experience with IQ/OQ/PQ

Qualifications

• Bachelor’s degree in engineering or life sciences required.
• CQV and process-equipment qualification experience in GMP-regulated environments.
• Experience with CIP/SIP skids, vessels, tanks, filtration systems.
• Hands-on experience with Kaye Validator for thermal mapping.
• Knowledge of IQ/OQ/PQ execution, test protocols, and validation reporting.
• Ability to interpret P&IDs, drawings, and vendor docs; familiarity with automation controls is a plus.

Responsibilities

• Plan and execute commissioning and qualification activities for pharmaceutical process equipment, skids, vessels, preparation and holding tanks, and associated process systems.
• Develop and review lifecycle documentation, including URS, risk assessments, design reviews, commissioning tests, IQ/OQ/PQ protocols, traceability matrices, and final reports.
• Verify equipment installation, instrumentation, calibration, alarms, interlocks, control sequences, operating ranges, and critical process parameters against approved requirements.
• Plan and execute temperature-mapping and qualification studies for freezers, incubators, cold rooms, and other temperature-controlled units.
• Set up, configure, operate, and troubleshoot Kaye Validator and associated data-acquisition equipment for thermal studies.
• Prepare, label, position, calibrate, and verify thermocouples or temperature sensors before and after study execution.
• Conduct empty and loaded mapping studies, including door-opening, power-failure, recovery, alarm, and other challenge tests where applicable.
• Review and analyse temperature data, identify hot and cold spots, evaluate excursions and recovery performance, and confirm compliance with approved acceptance criteria.
• Document and investigate discrepancies, deviations, failed tests, and atypical results. Support root-cause assessments, corrective actions, and timely closure.
• Coordinate field execution, system turnover, and documentation closure with equipment owners, vendors, and cross-functional stakeholders.
• Support change controls, periodic reviews, requalification planning, audit readiness, and ad hoc CQV activities while maintaining complete and traceable records.

Skills

Technical writing

Data analysis

Troubleshooting

Planning

Stakeholder mgmt

GMP knowledge

Temperature mapping

Education

Bachelor's degree in Engineering, Life Sciences, Pharmaceutical Science

Tools

Kaye Validator

Kaye AVS

Job description

CQV Engineer

Process Equipment | Kaye Validator | Thermal Mapping

Role Overview

The CQV Engineer will plan, execute, and document commissioning and qualification activities for pharmaceutical process equipment, temperature-controlled units, and storage areas within a GMP-regulated environment.

The role combines hands-on equipment CQV with Kaye-based thermal mapping and requires close coordination with Engineering, Quality, Operations, Automation, Metrology, and vendors to deliver compliant and inspection-ready validation packages.

Key Responsibilities

• Plan and execute commissioning and qualification activities for pharmaceutical process equipment, skids, vessels, preparation and holding tanks, and associated process systems.
• Develop and review lifecycle documentation, including User Requirement Specifications (URS), risk assessments, design reviews, commissioning tests, IQ/OQ/PQ protocols, traceability matrices, and final reports.
• Verify equipment installation, instrumentation, calibration, alarms, interlocks, control sequences, operating ranges, and critical process parameters against approved requirements.
• Plan and execute temperature-mapping and qualification studies for freezers, incubators, cold rooms, and other temperature-controlled units.
• Set up, configure, operate, and troubleshoot Kaye Validator and associated data-acquisition equipment for thermal studies.
• Prepare, label, position, calibrate, and verify thermocouples or temperature sensors before and after study execution.
• Conduct empty and loaded mapping studies, including door-opening, power-failure, recovery, alarm, and other challenge tests where applicable.
• Review and analyse temperature data, identify hot and cold spots, evaluate excursions and recovery performance, and confirm compliance with approved acceptance criteria.
• Document and investigate discrepancies, deviations, failed tests, and atypical results. Support root-cause assessments, corrective actions, and timely closure.
• Coordinate field execution, system turnover, and documentation closure with equipment owners, vendors, and cross-functional stakeholders.
• Support change controls, periodic reviews, requalification planning, audit readiness, and ad hoc CQV activities while maintaining complete and traceable records.

Candidate Requirements

• Bachelor's degree in Engineering, Life Sciences, Pharmaceutical Science, or a related discipline.
• Relevant CQV and process-equipment qualification experience within the pharmaceutical, biotechnology, or another GMP-regulated environment.
• Practical experience qualifying process equipment such as CIP/SIP skids, vessels, preparation or holding tanks, filtration, transfer, or comparable manufacturing systems.
• Hands-on experience using Kaye Validator or Kaye AVS for temperature mapping and thermal qualification studies.
• Practical experience qualifying freezers, incubators, cold rooms, or comparable temperature-controlled equipment and facilities.
• Good understanding of IQ/OQ/PQ execution, functional testing, sensor placement, calibration, data acquisition, deviations, and validation reporting.
• Able to interpret P&IDs, equipment specifications, engineering drawings, and vendor documentation. Familiarity with automated control systems would be advantageous.
• Working knowledge of GMP, Good Documentation Practices, data integrity, change control, and validation lifecycle requirements.
• Strong technical-writing, data-analysis, troubleshooting, planning, and stakeholder-management skills.