Process Validation Engineer

Katalyst Healthcares & Life Sciences

Indianapolis, IN

JOB DETAILS
SKILLS
Computer Systems, Continuous Improvement, Detail Oriented, Document Management, Documentation, Equipment Validation, Laboratory Equipment, Lean Six Sigma, Maintain Compliance, Process Engineering, Process Validation, Project Tracking, Pumps, Regulatory Compliance, Regulatory Requirements, Six Sigma Certification, Support Documentation, System Validation, Temperature Mapping
LOCATION
Indianapolis, IN
POSTED
30+ days ago
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.

About the Company

K

Katalyst Healthcares & Life Sciences