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

·        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