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Process Validation Engineer
Job in
Bloomington, Monroe County, Indiana, 47401, USA
Listed on 2026-06-02
Listing for:
Katalyst Healthcares & Life Sciences
Full Time
position Listed on 2026-06-02
Job specializations:
-
Engineering
Systems Engineer, Quality Engineering
Job Description & How to Apply Below
Responsibilities:
- Lead migration of legacy documents into Kneat digital platform, ensuring compliance and consistency.
- Qualify redundant lab equipment (e.g., pH meters, thermal mixers, peristaltic pumps, nutating mixers) to ensure operational integrity.
- Perform equipment and temperature mapping studies, particularly for Ellab systems, based on project needs.
- Support Process Engineers by filling resource gaps, ensuring projects remain on track during critical milestones.
- Document and support Computer Systems Validation (CSV) tasks as needed to meet regulatory requirements.
- Bachelor's degree in Engineering, Science, or related field.
- Experience with equipment qualification, validation, or regulatory compliance.
- Familiarity with Kneat digital platform or similar document management systems.
- Strong understanding of CSV (Computer Systems Validation) principles.
- Knowledge of temperature mapping methodologies.
- Familiarity with Ellab systems or similar validation equipment.
- Lean/ Six Sigma certifications or continuous improvement experience is a plus.
- Excellent attention to detail and strong documentation skills.
- Ability to work independently and collaboratively in a fast-paced environment.
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