Validation Specialist
Job in
Richmond, Henrico County, Virginia, 23214, USA
Listed on 2026-10-05
Listing for:
Katalyst CRO
Full Time
position Listed on 2026-10-05
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist
Job Description & How to Apply Below
- 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.
- 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.
- 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 (Track Wise or similar), document management systems, and MS Office/Excel.
- CQE, CQA, ASQ, or similar certification preferred.
- IQ/OQ/PQ & Process Validation.
- Technical Writing & GMP Documentation.
- Cross-Functional Coordination & Factory-Floor Execution.
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