Analytical / QC Laboratory Equipment CQV Engineer at Advanced Manufacturing Tech Solutions (AMTSOL)

Singapore, , Singapore -

Full Time

Start Date

Immediate

Expiry Date

16 Oct, 26

Salary

0.0

Posted On

18 Jul, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Commissioning, Qualification, Validation, GMP, Risk Assessment, IQ/OQ/PQ, Analytical Equipment, Data Integrity, Technical Writing, Stakeholder Management, CSV, LIMS, FAT/SAT, Calibration, Temperature Mapping, CAPA

Industry

Pharmaceutical Manufacturing

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. 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.

Responsibilities

Lead the commissioning, qualification, and validation (CQV) activities for analytical and QC laboratory equipment in a GMP-regulated environment. Develop and execute qualification protocols, manage deviations, and ensure data integrity and compliance with regulatory standards.