QC Engineer

4 days ago


Singapore Unison Group Full time $90,000 - $120,000 per year

Role Overview

We are seeking a QC Engineer with strong experience in Computer System Validation (CSV) for analytical laboratory instruments /equipment. The role ensures compliance with 21 CFR Part 11, data integrity, and global validation standards in a regulated GMP environment.

Key Responsibilities

  • Lead CSV activities for analytical equipment or instruments and lab computerized systems (e.g., HPLC, GC, UV, LIMS, Empower).
  • Develop and execute validation deliverables: URS, risk assessments, IQ/OQ/PQ, RTM, and summary reports.
  • Ensure compliance with 21 CFR Part 11, Annex 11, ALCOA+ principles, and data integrity controls.
  • Evaluate and validate audit trails, security settings, and user access controls.
  • Support integration between instrument, PC, network, and enterprise systems.
  • Draft, review, and maintain SOPs, validation documentation, and audit readiness materials.
  • Contribute to lifecycle management of systems including periodic reviews, upgrades, and change control.
  • Collaborate with QA, QC, and IT to support inspection readiness and continuous improvement.

Requirements

  • Bachelor's degree in Chemistry, Life Sciences, Engineering, or related discipline.
  • 5–10 years' experience in analytical instrument/equipment CSV within pharmaceutical/biotech QC labs.
  • Strong knowledge of cGMP, GAMP 5, 21 CFR Part 11, Annex 11.
  • Hands-on experience with microbiology analytical equipment is an advantage.
  • Familiarity with electronic validation tools (e.g., Kneat) is preferred.
  • Strong documentation, troubleshooting, and cross-functional collaboration skills.

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