Lab Equipment Validation Engineer (GMP)

COALESCE MANAGEMENT CONSULTING PTE. LIMITED; Singapore; On-site; SGD 70,000 - 110,000; Full time

Job summary

COALESCE MANAGEMENT CONSULTING PTE. LIMITED in Singapore seeks a Validation Engineer to support commissioning, qualification and lifecycle management of laboratory equipment in a GMP-regulated environment.

You will develop and execute qualification documentation, coordinate testing activities and ensure equipment is compliant, fit for use and ready for routine operation across QC, QA, Engineering and vendor teams.

Qualifications

• Bachelor's degree in Engineering, Chemistry, Pharmaceutical Science, Biotechnology, Life Sciences or related discipline.
• Experience in laboratory equipment validation/qualification in GMP-regulated industry.
• Hands-on IQ, OQ and PQ protocol execution.
• Knowledge of GMP, data integrity, deviation management and change control.
• Familiarity with computerised system validation and regulatory expectations (21 CFR Part 11) is advantageous.
• Experience with electronic validation or quality-management systems such as Kneat, ValGenesis or TrackWise preferred.
• Strong technical-writing, troubleshooting, investigation and stakeholder-management abilities.

Responsibilities

• Plan, coordinate and execute qualification activities for QC and laboratory equipment.
• Develop, review and execute validation lifecycle documentation (URS, risk assessments, DQ/IQ/OQ/PQ; traceability matrices; qualification reports).
• Coordinate qualification activities with QC, Quality Assurance, Engineering, Metrology, Automation, IT, equipment vendors and other stakeholders.
• Verify installation, operating ranges, alarms, interlocks, user access, interfaces and critical functions against approved requirements.
• Support Factory Acceptance Testing, Site Acceptance Testing, commissioning and equipment start-up activities.
• Identify, document and resolve protocol discrepancies, test failures and deviations.
• Support root-cause investigations, impact assessments and CAPAs.
• Provide validation input into equipment change controls, system modifications, software upgrades, relocation and retirement activities.
• Support calibration, preventive maintenance, periodic review and requalification activities.
• Ensure qualification records and supporting evidence are complete, accurate, traceable and inspection-ready.
• Support internal audits, regulatory inspections and responses to equipment-validation queries.

Skills

Technical writing

Troubleshooting

Investigation

Stakeholder management

Organisational skills

Education

Bachelor's degree in Engineering / Chemistry / Pharmaceutical Science / Biotechnology / Life Sciences

Tools

Kneat

ValGenesis

TrackWise

Job description

COALESCE MANAGEMENT CONSULTING PTE. LIMITED in Singapore seeks a Validation Engineer to support commissioning, qualification and lifecycle management of laboratory equipment in a GMP-regulated environment.

You will develop and execute qualification documentation, coordinate testing activities and ensure equipment is compliant, fit for use and ready for routine operation across QC, QA, Engineering and vendor teams.