CQV Engineer – Analytical/QC Laboratory Equipment (Pharmaceutical) - Part-Time

About our client: Our client is a leading global pharmaceutical company.

About the role:

• Responsible for commissioning, qualification, and validation activities for analytical and QC laboratory equipment to ensure compliance with GMP requirements, regulatory standards, and company procedures.
• Develop and execute qualification protocols including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Perform commissioning and qualification activities for analytical/QC laboratory equipment such as HPLC/UHPLC, Gas Chromatography (GC), UV-Vis Spectrophotometers, TOC Analysers, Dissolution Systems, pH & Conductivity Meters, Balances, Laboratory Incubators, Ovens, and Refrigerators.
• Prepare and review qualification documents, risk assessments, validation protocols, and summary reports.
• Support FAT (Factory Acceptance Test), SAT (Site Acceptance Test), calibration, and vendor management activities.
• Perform temperature mapping activities and support equipment qualification lifecycle activities.
• Manage deviations, CAPAs, and change controls to ensure timely resolution and compliance.
• Ensure complete traceability from User Requirement Specifications (URS) through qualification testing and documentation.
• Support integration and verification of laboratory systems including LIMS, CDS, PCS, MES, and OSI PI Historian.
• Verify data integrity requirements including audit trails, user account management, security roles, electronic signatures, backup and restore functionality, and time synchronization.
• Collaborate with QA, QC, Engineering, Automation, IT teams, and vendors to ensure successful execution of qualification activities.

About you:

• Bachelor’s Degree in Engineering, Life Sciences, Pharmaceutical Sciences, Chemistry, or related discipline.
• Minimum 5 years of experience in Commissioning, Qualification & Validation (CQV) activities for analytical and QC laboratory equipment within pharmaceutical, biotechnology, or GMP-regulated environments.
• Strong understanding of GMP requirements, Data Integrity principles (ALCOA+), and qualification lifecycle processes.
• Hands-on experience in executing IQ/OQ/PQ protocols and managing qualification documentation.
• Experience in risk assessments, deviation management, change controls, and validation reporting.
• Familiarity with chromatography data systems such as Empower or Chromeleon and knowledge of Computer System Validation (CSV) requirements will be advantageous.
• Knowledge of regulatory requirements including FDA, EU GMP, and PIC/S guidelines is preferred.
• Strong technical writing and documentation skills with good analytical and problem-solving abilities.
• Excellent communication, stakeholder management, and coordination skills.
• Strong attention to detail with a proactive approach and ability to work independently in a cross-functional environment.

Other:

• Employment Type: Contract
• Work Schedule: 5 days per week
• Location: Tuas, Singapore

*Please note that only shortlisted candidates will be contacted.*

Employment Agency: Kingsforce Management Services Pte. Ltd.

Employment Agency Licence No: 94C3545

EA Personnel: Kimberly Wong

EA Personnel Reg. No.: R1984508