Validation Engineer

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

Validation Engineer - Laboratory Equipment

Role Overview

The Validation Engineer will support the commissioning, qualification and lifecycle management of laboratory equipment and associated systems within a GMP-regulated pharmaceutical or biopharmaceutical environment.

The role involves developing and executing qualification documentation, coordinating testing activities and ensuring laboratory equipment is compliant, fit for its intended use and ready for routine operation.

Key Responsibilities

Plan, coordinate and execute qualification activities for QC and laboratory equipment.

Develop, review and execute validation lifecycle documentation, including:

• User Requirement Specifications (URS)
• Risk assessments
• Design Qualification (DQ)
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Traceability matrices
• Qualification summary reports

Support the qualification of laboratory equipment such as HPLC, GC, FTIR, UV-Vis spectrophotometers, balances, pH meters, stability chambers, refrigerators, freezers, incubators and other analytical instruments.

Review equipment specifications, engineering drawings, vendor documentation, calibration certificates, commissioning records and turnover packages.

Coordinate qualification activities with QC, Quality Assurance, Engineering, Metrology, Automation, IT, equipment vendors and other relevant stakeholders.

Verify equipment 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 where applicable.

Identify, document and resolve protocol discrepancies, test failures and deviations encountered during qualification execution.

Support root-cause investigations, impact assessments and implementation of corrective and preventive actions.

Provide validation input into equipment change controls, system modifications, software upgrades, relocation and retirement activities.

Support calibration, preventive maintenance, periodic review and requalification activities throughout the equipment lifecycle.

Ensure qualification records and supporting evidence are complete, accurate, traceable and inspection-ready.

Support internal audits, regulatory inspections and responses to equipment-validation queries.

Candidate Requirements

Bachelor's degree in Engineering, Chemistry, Pharmaceutical Science, Biotechnology, Life Sciences or a related discipline.

Relevant experience in laboratory equipment validation, commissioning or qualification within the pharmaceutical, biotechnology or another GMP-regulated industry.

Hands-on experience preparing and executing IQ, OQ and PQ protocols for laboratory equipment.

Practical knowledge of laboratory instruments, temperature-controlled equipment or associated computerised systems.

Able to review technical specifications, equipment manuals, vendor documentation, calibration records and qualification evidence.

Good understanding of GMP, Good Documentation Practices, data integrity, deviation management, change control and validation lifecycle requirements.

Familiarity with computerised-system validation and regulatory expectations such as 21 CFR Part 11 would be advantageous.

Experience using electronic validation or quality-management systems such as Kneat, ValGenesis or TrackWise is preferred.

Strong technical-writing, troubleshooting, investigation, organisation and stakeholder-management skills.

Able to work independently while collaborating effectively with laboratory, quality, engineering and vendor teams.