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.