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 ( freezers, incubators, 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.
Qualifications & Requirements
- Bachelor's degree in Engineering, Life Sciences, or related field.
- 2–5 years of 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.