CQV Engineer - Analytical Lab Equipment, GMP Validation

Advanced Manufacturing Tech Solutions PTE. LTD. (AMTSOL); Singapore; On-site; SGD 90,000 - 130,000; Full time

Job summary

AMTSOL is seeking an experienced CQV Engineer to lead commissioning, qualification, and validation activities for analytical and QC lab equipment within a GMP environment in Singapore.

The role requires hands-on CQV, strong technical writing, and cross-functional coordination with QA/QC, Engineering, IT, and vendors onsite in Singapore. Candidates mobilising by mid-August 2026 or by 1 September 2026 will be prioritized.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Pharmaceutical Sciences, Chemistry, or related discipline.
• Minimum 5 years of hands-on CQV experience with analytical or QC laboratory equipment in GMP-regulated environments.
• Strong understanding of equipment qualification lifecycle, GMP, ALCOA+ data-integrity principles, and Good Documentation Practices.
• Demonstrated experience authoring and reviewing qualification protocols, risk assessments, deviations, and final reports.
• Strong technical writing, problem-solving, planning, and cross-functional stakeholder-management skills.
• Experience supporting pharmaceutical or biotechnology manufacturing facilities and vendor-led qualification activities.

Responsibilities

• Develop, review, and execute qualification protocols and lifecycle documentation, including risk assessments, IQ, OQ, PQ, traceability matrices, discrepancy records, and summary reports.
• Perform commissioning and qualification of analytical and QC laboratory equipment, including HPLC/UHPLC, GC, UV-Vis spectrophotometers, TOC analyzers, dissolution systems, pH and conductivity meters, balances, incubators, ovens, refrigerators, and related laboratory systems.
• Support FAT, SAT, calibration, vendor documentation review, installation verification, and equipment handover activities.
• Plan and execute temperature mapping activities for laboratory-controlled temperature equipment where required.
• Verify computerized equipment controls and data-integrity features, including audit trails, user access, security roles, electronic signatures, backup/restore, and time synchronization.
• Support interface and integration testing involving LIMS, chromatography data systems, PCS, MES, or historian platforms, where applicable.
• Manage deviations, CAPAs, change controls, punch-list items, and discrepancy resolution through closure.
• Coordinate with QA, QC, Engineering, Automation, IT, vendors, and project stakeholders to meet qualification milestones.
• Maintain complete, inspection-ready documentation in accordance with GMP and Good Documentation Practices.

Skills

Technical writing

Problem-solving

Planning

Stakeholder management

Cross-functional collaboration

Education

Bachelor's degree in Engineering or Life Sciences

Tools

HPLC/UHPLC

GC

UV-Vis spectrophotometers

TOC analyzers

Dissolution systems

pH and conductivity meters

Calibration equipment (balances, incubators, ovens, refrigerators)

LIMS/Chromatography data systems

Empower/Chromeleon (CDS)

Job description

AMTSOL is seeking an experienced CQV Engineer to lead commissioning, qualification, and validation activities for analytical and QC lab equipment within a GMP environment in Singapore.

The role requires hands-on CQV, strong technical writing, and cross-functional coordination with QA/QC, Engineering, IT, and vendors onsite in Singapore. Candidates mobilising by mid-August 2026 or by 1 September 2026 will be prioritized.