Senior QA Validation Engineer

Coalesce Management Consulting; Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

Coalesce Management Consulting in Singapore is seeking an experienced QA professional to provide oversight for commissioning, qualification and validation (CQV) activities within a GMP-regulated environment. You will collaborate with Engineering, Validation, Manufacturing, Automation, QC and project teams to ensure systems are compliant and ready for use.

The role emphasizes reviewing validation plans, URS, risk assessments, IQ/OQ/PQ protocols, test scripts and release documentation, ensuring

Qualifications

• Degree in Engineering, Life Sciences, Biotechnology, Pharmaceutical Science, or related field.
• Experience in QA, validation, commissioning, qualification, engineering, or project quality in GMP.
• Knowledge of 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.

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.

Skills

QA oversight

Validation lifecycle

GMP knowledge

Documentation review

Stakeholder management

Education

Degree in Engineering / Life Sciences

Job description

ROLE OVERVIEW

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.

CANDIDATE REQUIREMENTS

• Degree 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.

CMC is an equal opportunity employer. We welcome applications from individuals of all ages and backgrounds and assess candidates solely on merit, skills, and potential. No terminology in this advert is intended to discriminate in any way.

We welcome applications/enquiries from individuals of all backgrounds and are committed to providing equal access to employment opportunities across all regions in which we operate.