Validation Specialist

Katalyst CRO; Denver (CO); On-site; USD 90,000 - 120,000; Full time

Job summary

Katalyst CRO in Denver, Colorado seeks a Senior Validation Engineer to lead hands-on validation activities for GMP equipment and utilities. You will execute IQ/OQ/PQ, support commissioning, and generate compliant documentation.

The role requires a Bachelor's degree in Engineering or Life Sciences and 5+ years of validation experience. You will collaborate across Engineering and Operations, assist with investigations, CAPAs, and participate in audit readiness.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related discipline.
• Minimum of 5+ years hands-on validation experience with GMP equipment and utilities.
• Experience with IQ/OQ/PQ, requalification and periodic reviews.

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

Documentation

GMP

QA Collaboration

Education

Bachelor's degree in Engineering/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.