Senior Validation Specialist - GMP Equipment & Utilities

Katalyst CRO; Tucson (AZ); On-site; USD 95,000 - 125,000; Full time

Job summary

Katalyst CRO in Tucson, AZ, is seeking a senior validation professional to lead and support validation activities for GMP equipment and utilities. The role requires executing IQ/OQ/PQ, requalification, and periodic reviews while ensuring compliance with cGMP, GDP, and SOP requirements.

You will collaborate with Engineering and Operations on commissioning, installation, and qualification of new or modified equipment, and participate in audits and regulatory inspections.

Qualifications

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

GMP / cGMP

Documentation

Audit readiness

CAPA & change controls

Equipment qualification

IQ/OQ/PQ

Temperature mapping

Education

Bachelor's degree in Engineering/Life Sciences

Job description

Katalyst CRO in Tucson, AZ, is seeking a senior validation professional to lead and support validation activities for GMP equipment and utilities. The role requires executing IQ/OQ/PQ, requalification, and periodic reviews while ensuring compliance with cGMP, GDP, and SOP requirements.

You will collaborate with Engineering and Operations on commissioning, installation, and qualification of new or modified equipment, and participate in audits and regulatory inspections.