Process Validation Engineer

Katalyst Healthcares and Life Sciences

Indianapolis, IN

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.

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.
bility to work independently and collaboratively in a fast-paced environment.

Apply

Vacancy posted 2 days ago

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