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Process Validation Engineer

Katalyst CRO

3.7
51 reviews
Katalyst CRO
Job Type   /   Job Level
Contract   /   Junior Executive
Job Location
Indianapolis, IN
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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.
  • Ability to work independently and collaboratively in a fast-paced environment.
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