Process Validation Engineer

Katalyst CRO; Bloomington (IN); On-site; USD 60,000 - 80,000; Full time

Job summary

Katalyst CRO in Bloomington, Indiana is seeking a qualified candidate to lead the migration of legacy documents into the Kneat digital platform and to qualify lab equipment to ensure operational integrity. The ideal candidate will have a Bachelor's degree in Engineering or Science and experience in regulatory compliance and equipment qualification. Strong attention to detail and documentation skills are essential. Join a collaborative and fast-paced environment where you can make a significant impact.

Qualifications

• Bachelor's degree in Engineering, Science, or related field.
• Experience with equipment qualification, validation, or regulatory compliance.
• Familiarity with Kneat digital platform or similar systems.

Responsibilities

• Lead migration of legacy documents into Kneat digital platform.
• Qualify redundant lab equipment to ensure operational integrity.
• Perform equipment and temperature mapping studies.

Skills

Equipment qualification

Regulatory compliance

Attention to detail

Strong documentation skills

CSV principles

Education

Bachelor's degree in Engineering, Science, or related field

Tools

Kneat digital platform

Ellab systems

Job description

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.