Lead CQV for Analytical Lab Equipment | GMP | Singapore

Advanced Manufacturing Tech Solutions PTE. LTD. (AMTSOL); Singapore; On-site; SGD 90,000 - 150,000; Full time

Job summary

AMTSOL in Singapore seeks an experienced CQV Engineer to lead commissioning, qualification, and validation of analytical and QC lab equipment within a GMP-regulated environment.

You will develop and execute qualification protocols (IQ/OQ/PQ), coordinate with QA and vendors, and ensure traceability and data integrity across instruments such as HPLC, UV-Vis, TOC, and dissolution systems. Onsite support in Singapore with mid-2026 start.

Qualifications

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

Responsibilities

• Develop, review, and execute qualification protocols and lifecycle documentation, including IQ, OQ, PQ, traceability matrices, discrepancy records, and summary reports.
• Perform commissioning and qualification of analytical and QC laboratory equipment (HPLC/UHPLC, GC, UV-Vis spectrophotometers, TOC analyzers, dissolution systems, pH and conductivity meters, balances, incubators, ovens, refrigerators).
• 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 (audit trails, user access, security roles, electronic signatures, backup/restore, 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

Cross-functional collaboration

Education

Bachelor's degree in Engineering or related discipline

Tools

Empower

Chromeleon

LIMS

PCS

MES

Job description

AMTSOL in Singapore seeks an experienced CQV Engineer to lead commissioning, qualification, and validation of analytical and QC lab equipment within a GMP-regulated environment.

You will develop and execute qualification protocols (IQ/OQ/PQ), coordinate with QA and vendors, and ensure traceability and data integrity across instruments such as HPLC, UV-Vis, TOC, and dissolution systems. Onsite support in Singapore with mid-2026 start.