CQV Engineer
20 hours ago
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
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