GMP Lab Equipment Validation Engineer

Coalesce Management Consulting; Singapore; On-site; SGD 60,000 - 100,000; Full time

Job summary

Coalesce Management Consulting seeks a Validation Engineer to support commissioning, qualification and lifecycle management of laboratory equipment in a GMP-regulated pharmaceutical or biopharmaceutical setting.

You will develop and execute qualification documentation, coordinate testing activities and ensure equipment readiness for routine operation. The role requires hands-on IQ/OQ/PQ execution and strong collaboration with QC, QA, engineering and vendors.

Qualifications

• Bachelor’s degree or higher in a relevant science/engineering discipline.
• Experience validating laboratory equipment in GMP/regulated environments.
• Hands-on experience preparing/executing IQ/OQ/PQ protocols.
• Familiarity with calibration records and qualification evidence.
• Knowledge of data integrity, deviation management, and change controls.
• Experience with computerised validation systems is a plus.

Responsibilities

• Plan, coordinate and execute qualification activities for QC and laboratory equipment.
• Develop and review validation lifecycle documentation (URS, risk assessments, DQ, IQ, OQ, PQ).
• Coordinate activities with QC, QA, Engineering, Metrology, IT and vendors.
• Verify equipment installation, operating ranges, alarms and critical functions against requirements.
• Support site and factory acceptance testing, commissioning and start-up activities.
• Document and resolve deviations, test failures and CAPA.
• Provide validation input into change controls and system modifications.
• Support ongoing calibration and requalification throughout equipment lifecycle.

Skills

GMP knowledge

IQ/OQ/PQ protocols

Documentation & data integrity

Stakeholder management

Education

Bachelor’s degree in Engineering, Chemistry, Pharmaceutical Science, Biotechnology, Life Sciences or related discipline

Tools

Kneat

ValGenesis

TrackWise

Job description

Coalesce Management Consulting seeks a Validation Engineer to support commissioning, qualification and lifecycle management of laboratory equipment in a GMP-regulated pharmaceutical or biopharmaceutical setting.

You will develop and execute qualification documentation, coordinate testing activities and ensure equipment readiness for routine operation. The role requires hands-on IQ/OQ/PQ execution and strong collaboration with QC, QA, engineering and vendors.