QC Engineer

4 days ago

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

We are looking for a QC Engineer with hands-on expertise in temperature mapping of controlled chambers. The role supports qualification, documentation, and lifecycle compliance of temperature-controlled environments in a GMP-regulated setting.

  • Plan, execute, and document temperature mapping studies for chambers (cold rooms, freezers, incubators, stability chambers).
  • Prepare and review validation protocols, reports, and deliverables in Kneat or equivalent systems.
  • Perform data integrity assessments and ensure compliance with GDP and ALCOA+ principles.
  • Draft and maintain SOPs for temperature mapping and chamber qualification.
  • Support deviation management, change control, and CAPA implementation.
  • Provide technical input for requalification planning and continuous improvement.
  • Collaborate with QC, QA, and Engineering to support audit and inspection readiness.

Requirements

  • Good experience in temperature mapping of chambers within pharmaceutical/biotech or regulated industries.
  • Knowledge of GDP, ALCOA+ principles, and qualification practices.
  • Familiarity with mapping across a variety of chambers is advantageous.
  • Experience with validation documentation and use of Kneat preferred.
  • Strong technical writing, data review, and teamwork skills.

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