
Controlled Chamber Validation Specialist
14 hours ago
We are seeking a skilled Temperature Mapping Engineer to join our team. As a key member of our organization, you will be responsible for planning and executing temperature mapping studies for controlled chambers, drafting validation protocols and reports, and performing equipment qualification activities.
About the Role- This is an opportunity to work in a dynamic environment where you can utilize your technical skills to drive quality and compliance within our operations.
The ideal candidate will have a strong background in engineering, life sciences, or a related field, with 2-5 years of experience in temperature mapping and qualification activities.
Key Responsibilities- Plan and execute temperature mapping studies for various controlled chambers, including freezers and incubators.
- Draft and execute validation protocols, reports, and data integrity assessments in compliance with GDP and Alcoa principles.
- Perform equipment qualification activities (IQ/OQ/PQ) in accordance with regulatory requirements.
- Develop and review SOPs, deviation reports, and CAPAs related to temperature mapping.
- Collaborate with QA, engineering, and operations teams to ensure compliant practices.
- Bachelor's degree in engineering, life sciences, or a related field.
- 2-5 years of experience in temperature mapping and qualification activities.
- Strong knowledge of GDP and Alcoa principles.
- Familiarity with Kneat protocol authoring is preferred.
- Experience with temperature-controlled chambers is advantageous.
- Excellent documentation and communication skills.
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