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.