Analytical QC Laboratory Equipment CQV Engineer

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

• 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
  
• Bachelors 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.