Process Validation Engineer

Katalyst CRO; Bloomington (IN); Presencial; USD 100.000 - 140.000; Jornada completa

Descripción de la vacante

Katalyst CRO in Bloomington, IN is seeking a qualified engineer to lead documentation migration and equipment qualification within Kneat-based CSV projects.

You will validate equipment, perform temperature mapping, and support Process Engineers while ensuring regulatory compliance and robust documentation.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Equipment qualification

Validation

CSV principles

Kneat familiarity

Documentation

Regulatory compliance

Educación

Bachelors in Eng/Science

Herramientas

Kneat platform

Ellab systems

Descripción del empleo

• 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.

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.