Quality Assurance Engineer

Coalesce Management Consulting; Singapore; On-site; SGD 90,000 - 130,000; Full time

Job summary

Coalesce Management Consulting seeks a Quality Assurance Validation Engineer to oversee the commissioning, qualification, and validation of equipment, facilities, and systems in a GMP environment. You will coordinate QA input across validation activities, review plans and protocols, and ensure data integrity and regulatory readiness.

You will work with engineering, validation, manufacturing, and project teams to ensure systems are appropriately qualified and suitable for intended use, supporting

Qualifications

• Degree or diploma in Engineering, Life Sciences, Biotechnology, Pharmaceutical Science, or related discipline.
• Experience in QA, validation, commissioning, qualification, or project quality in GMP environments.
• Knowledge of validation lifecycle and qualification principles for equipment, facilities, or systems.

Responsibilities

• Provide QA oversight across CQV lifecycle for equipment, facilities, utilities, and systems.
• Review validation plans, protocols, and release documentation for completeness.
• Ensure compliance with GMP expectations and data integrity requirements.
• Assess discrepancies and ensure resolution before system release.

Skills

Quality mindset

Documentation review

Stakeholder management

Problem solving

Communication

Education

Bachelor's degree in Engineering or related discipline

Tools

Validation protocols (IQ/OQ/PQ)

URS & risk assessments

Change control

Job description

We are looking for a Quality Assurance Validation Engineer to provide quality oversight for equipment and system Commissioning, Qualification and Validation projects in a GMP-regulated environment. The role works closely with Engineering, Validation, Manufacturing, Automation, QC, and project teams to ensure systems are compliant, appropriately qualified, and suitable

for intended use.

Key Responsibilities

• Provide QA oversight throughout the commissioning, qualification, and validation lifecycle for equipment, facilities, utilities, and associated systems.
• Review and approve validation plans, URS, risk assessments, DQ/IQ/OQ/PQ protocols, test scripts, traceability documents, summary reports, and system-release packages.
• Ensure CQV execution follows approved procedures, predefined acceptance criteria, GMP expectations, and data integrity requirements.
• Assess protocol discrepancies, deviations, test failures, and corrective actions; confirm appropriate resolution before system release.
• Provide QA input to change controls, validation impact assessments, design changes, system modifications, and requalification strategies.
• Review vendor and engineering documentation, turnover packages, calibration records, drawings, and supporting evidence for completeness and traceability.
• Participate in project meetings, communicate compliance risks, and support timely closure of qualification deliverables.
• Support final QA release and handover of qualified systems, inspection readiness, internal audits, and regulatory inspections.

Requirements

• Degree or diploma in Engineering, Life Sciences, Biotechnology, Pharmaceutical Science, or a related discipline.
• Relevant QA, validation, commissioning, qualification, engineering, or project quality experience in a GMP-regulated industry.
• Knowledge of the validation lifecycle and qualification principles for equipment, facilities, utilities, or automated systems.
• Familiarity with URS, risk assessments, DQ, IQ, OQ, PQ, validation protocols, deviations, change control, and summary reports.
• Strong technical review, documentation, problem-solving, communication, and stakeholder-management capabilities