CQV Engineer - Analytical / QC Laboratory Equipment
5500 - 8500 SGDFull-time
ADVANCED MANUFACTURING TECH SOLUTIONS PTE. LTD.
AMTSOL is hiring for a greenfield pharmaceutical project in Singapore and is seeking an experienced CQV Engineer to lead the commissioning, qualification, and validation of 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.
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.
Vacancy posted 3 days ago
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