Qc Engineer Temperature Mapping

Kuala Lumpur, M14, MY, Malaysia

Job Description

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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Job Detail

  • Job Id
    JD1207649
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Kuala Lumpur, M14, MY, Malaysia
  • Education
    Not mentioned