Manufacturing Qualification Specialist

Execution of qualification activities (IQ/OQ/PQ) for manufacturing equipment, processes, and Materials within Enterprise Quality – Change Management & Systems. Supports the Change Control & Qualification team's protocol execution, documentation, traceability and record management workload. Day-to-day direction from Manager

This is a hands-on execution role supporting equipment and process qualification activities within a manufacturing environment. The contractor will draft, execute and close out Installation, Operational and Performance Qualification (IQ/OQ/PQ) protocols for manufacturing equipment and systems. They will generate qualification reports, document results and ensure full traceability of records in accordance with internal procedures and applicable regulatory requirements. The role requires close coordination on the factory floor with Manufacturing, Engineering, Quality and Project teams to complete qualification testing around production windows. The contractor will also support documentation remediation, record management and change-control linkage for qualified equipment. This is an execution role, not a strategy or program-design role; success is measured by timely, right-first-time completion of qualification deliverables.

Qualifications:
• Bachelor's degree in a technical discipline (equivalent hands-on qualification experience considered in lieu of degree)
• 5+ years executing equipment qualification (IQ/OQ/PQ) and process validation in a GMP or otherwise regulated manufacturing environment
• Demonstrated experience authoring and executing protocols and writing summary reports, including deviation/discrepancy documentation and traceability
• Working proficiency with electronic quality systems (e.g., TrackWise or comparable eQMS), document management systems and MS Office/Excel; validation or quality certification (CQE, CQA, ASQ or similar) preferred

Top 3 Skills:
1. Hands-on equipment qualification and process validation execution (IQ/OQ/PQ)
2. Technical writing - protocol authoring, report generation and GMP-compliant documentation
3. Cross-functional coordination and self-directed execution in a live factory environment