Validation Specialist

Katalyst CRO; Denver (CO); On-site; USD 90,000 - 125,000; Full time

Job summary

Katalyst CRO in Denver, CO seeks a Senior Validation Engineer to lead GMP validation activities for equipment and processes. The role focuses on IQ/OQ/PQ, cleanliness validation, temperature mapping, and documentation to support cGMP compliance.

You will collaborate with Engineering and Operations, assist with commissioning and qualification of new or modified equipment, and contribute to audit readiness and regulatory inspections.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related discipline required.
• 5+ years of hands-on validation experience with GMP equipment and utilities.

Responsibilities

• Support cleaning validation activities, protocol execution, sampling, and documentation.
• Perform temperature mapping and requalification of controlled temperature units.
• Execute IQ/OQ/PQ, requalification, and periodic review for GMP equipment and utilities.
• Support commissioning, installation, and qualification of new or modified equipment.
• Assist with equipment troubleshooting alongside Engineering and Operations.
• Generate validation documentation following cGMP, GDP, and SOP requirements.
• Support validation lifecycle activities, change controls, investigations, and CAPAs.
• Participate in audit readiness and regulatory inspection support.

Skills

Validation experience

GxP awareness

Documentation

Cross-functional collaboration

Education

Bachelor's degree in Engineering or Life Sciences

Job description

• Support cleaning validation activities, protocol execution, sampling, and documentation.
• Perform temperature mapping and requalification of controlled temperature units.
• Execute IQ/OQ/PQ, requalification, and periodic review for GMP equipment and utilities.
• Support commissioning, installation, and qualification of new or modified equipment.
• Assist with equipment troubleshooting alongside Engineering and Operations.
• Generate validation documentation following cGMP, GDP, and SOP requirements.
• Support validation lifecycle activities, change controls, investigations, and CAPAs.
• Participate in audit readiness and regulatory inspection support.
• Bachelor's degree in Engineering, Life Sciences, or related discipline required.
• 5+ years of hands-on validation experience with GMP equipment and utilities.