KH
Process Validation Engineer
Katalyst Healthcares & Life Sciences
🇺🇸 United States
On-site
5 months ago
- Regulatory Compliance
- Lean Six Sigma
5 months ago
Not enough detail in this posting to match
- 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.
Process Validation Engineer · Katalyst Healthcares & Life Sciences