Analytical / QC Laboratory Equipment CQV Engineer

Advanced Manufacturing Tech Solutions; Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

Advanced Manufacturing Tech Solutions is looking for an experienced CQV Engineer to lead commissioning, qualification and validation of analytical and QC laboratory equipment in a GMP-regulated setting in Singapore. You will develop and execute IQ/OQ/PQ protocols, review risk assessments, and coordinate with QA, QC, Engineering, IT and vendors to meet milestones.

Strong technical writing and cross‑functional collaboration are essential.

Qualifications

• 5+ years hands-on CQV experience with analytical or QC lab equipment in GMP-regulated environments.
• Bachelor's degree in Engineering, Life Sciences, or related field.
• Strong understanding of qualification lifecycle, ALCOA+ data integrity, and Good Documentation Practices.
• Experience authoring and reviewing qualification protocols, risk assessments, deviations, and final reports.
• Strong technical writing and cross-functional stakeholder management.

Responsibilities

• Develop, review, and execute qualification protocols and lifecycle docs (IQ/OQ/PQ) with risk assessments and reports.
• Qualify analytical and QC lab equipment (HPLC/UHPLC, GC, UV-Vis, TOC analyzers, dissolution systems, meters).
• Support FAT, SAT, calibration, installation verification, and equipment handover activities.
• Plan and execute temperature mapping for lab equipment where required.
• Verify computerized controls and data integrity features (audit trails, signatures, time sync).
• Support interface and integration testing with LIMS, CDS, PCS, MES, and historian platforms.
• Manage deviations, CAPAs, change controls, punch-lists, and discrepancy closures.
• Coordinate with QA/QC/Engineering/IT/vendors to meet qualification milestones.
• Maintain inspection-ready GMP documentation.

Skills

Cross-functional stakeholder mgmt

Technical writing

Problem solving

Project coordination

Quality mindset

Education

Bachelor's degree in Engineering/Life Sciences/Pharma

Tools

HPLC/UHPLC

GC

UV-Vis spectrophotometers

TOC analyzers

Dissolution systems

pH meters

Conductivity meters

Balances

Incubators

Ovens

Refrigerators

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 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.

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.
• 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.