What are the responsibilities and job description for the Validation Engineer position at Katalyst Healthcares & Life Sciences?
Job Description
Job Description
Responsibilities :
- Work under the direction of the Validation Lead and / or function as the validation lead for a project team. The Validation Engineer will be required to support multiple projects simultaneously.
- Develop and execute IQ, OQ, and PQ protocols for products, processes, facilities, software, and equipment within the facility.
- Experience authoring Validation Plan documents, User Requirements, Traceability Matrix, and Validation Summary Reports.
- Write reports summarizing results and statistics for all equipment, products, or process validation projects.
- Work with end users and process owners to collect data to support protocol requirements, analyze data collected, and create validation reports.
- Coordinate with end users and process owners to lead the development of validation protocols.
- Learn and understand the applicable technology and engage in technical discussions.
- Identify areas and opportunities to improve manufacturing facilities, processes, and equipment.
- Provide consultation to other departments performing validation activities.
- Ensure the validation program meets FDA and Site-Specific requirements.
Requirements :
