Validation Specialist

Katalyst CRO; Richmond (VA); On-site; USD 83,000 - 145,000; Full time

Job summary

Katalyst CRO is seeking a hands-on Equipment Qualification & Process Validation Contractor to support the Enterprise Quality Change Management & Systems organization. You will execute IQ/OQ/PQ for manufacturing equipment, processes, and materials in a regulated environment, delivering right-first-time qualification deliverables on the factory floor.

Reporting to the Manager, you will author protocols and reports, manage deviations with full traceability, and coordinate activities with

Qualifications

• Bachelor's degree in a technical discipline or equivalent experience.
• 5+ years of IQ/OQ/PQ and process validation experience in GMP or regulated manufacturing.
• Experience with protocol writing, execution, reports, deviations, and traceability.
• Proficiency with eQMS (TrackWise or similar), document management systems, and MS Office/Excel.
• CQE, CQA, ASQ, or similar certification preferred.

Responsibilities

• Execute and close IQ/OQ/PQ protocols for manufacturing equipment and systems.
• Author protocols, qualification reports, and GMP-compliant documentation.
• Document deviations/discrepancies and maintain full record traceability.
• Coordinate qualification activities with Manufacturing, Engineering, Quality, and Project teams.
• Support change control, documentation remediation, and record management.
• Execute qualification activities on the factory floor around production schedules.

Skills

IQ/OQ/PQ

Technical Writing

Cross-functional coordination

Education

Bachelor's degree in a technical discipline

Tools

eQMS TrackWise

MS Office/Excel

Job description

Job Summary

• We are seeking a hands-on Equipment Qualification & Process Validation Contractor to support the Enterprise Quality Change Management & Systems organization.
• The contractor will be responsible for executing qualification activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), for manufacturing equipment, processes, and materials within a regulated manufacturing environment.
• This is an execution-focused role, with day-to-day direction from the Manager.
• Success will be measured by the timely, accurate, and right-first-time completion of qualification deliverables.

Responsibilities

• Execute and close IQ/OQ/PQ protocols for manufacturing equipment and systems.
• Author protocols, qualification reports, and GMP-compliant documentation.
• Document deviations/discrepancies and maintain full record traceability.
• Coordinate qualification activities with Manufacturing, Engineering, Quality, and Project teams.
• Support change control, documentation remediation, and record management.
• Execute qualification activities on the factory floor around production schedules.

Qualifications

• Bachelor's degree in a technical discipline or equivalent experience.
• 5+ years of hands-on IQ/OQ/PQ and process validation experience in GMP or regulated manufacturing.
• Experience with protocol writing, execution, reports, deviations, and traceability.
• Proficiency with eQMS (TrackWise or similar), document management systems, and MS Office/Excel.
• CQE, CQA, ASQ, or similar certification preferred.

Top 3 Skills

• IQ/OQ/PQ & Process Validation.
• Technical Writing & GMP Documentation.
• Cross-Functional Coordination & Factory-Floor Execution.