Quality Control Engineer - Temperature Mapping

Description

• 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.

Responsibilities

• 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.