Analytical / QC Laboratory Equipment CQV Engineer

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

Overview

AMTSOL is supporting a pharmaceutical manufacturing project in Singapore and is seeking an experienced CQV Engineer to lead commissioning, qualification, and validation activities for analytical and QC laboratory equipment within a GMP-regulated environment.

Location -Singapore

Industry -Life Sciences / Pharmaceutical Manufacturing

Experience Required -5+ years

Project Start Date -Mid-August 2026; latest commencement by 1 September 2026

Key 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.

Requirements

• Bachelor's degree in Engineering, Life Sciences, Pharmaceutical Sciences, Chemistry, or a related discipline.
• Minimum 5 years of hands‑on CQV experience with analytical or QC laboratory equipment in pharmaceutical, biotechnology, or another GMP-regulated environment.
• 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.
  The role is expected to provide onsite project support in Singapore.
  Candidates able to mobilise by mid‑August 2026, or no later than 1 September 2026, will be prioritised.

Preferred / Advantageous

• Experience with chromatography data systems such as Empower or Chromeleon and associated CSV requirements.
• Knowledge of FDA, EU GMP, and PIC/S expectations for laboratory equipment and computerized systems.