CQV Engineer - Temperature Mapping

Role Overview

We are seeking a CQV Engineer with specialized experience in temperature mapping of controlled temperature chambers in GMP/GDP environments. The role requires strong knowledge of GDP principles, ALCOA data integrity standards, and experience authoring protocols and reports in Kneat.

Key Responsibilities

• Plan and execute temperature mapping studies for a variety of controlled chambers (refrigerators, freezers, incubators, warehouses, etc.)
• Draft and execute validation protocols, reports, and data integrity assessments
• Perform equipment qualification activities (IQ/OQ/PQ) in compliance with GDP and ALCOA principles
• Develop and review SOPs, deviation reports, and CAPAs related to temperature mapping
• Support audits and inspections by providing validation evidence
  
  

Collaborate with QA, Engineering, and Operations to ensure compliant practices

Requirements

• Bachelor's degree in Engineering, Life Sciences, or related field
• Experience in temperature mapping and qualification activities
• Strong knowledge of GDP and ALCOA principles
• Experience drafting protocols and reports in Kneat preferred
• Familiarity with a wide range of temperature-controlled chambers advantageous
  
  

Strong documentation skills