Quality Engineer - Equipment Qualification

Job Title: Quality Engineer – Equipment Qualification

Duration: 06 Months

Shift : 1st Shift

Location: Richmond, VA 23234

Pay Rate: $57.97/Hour on W2

Job Mode: Onsite

Please double check you have the right level of experience and qualifications by reading the full overview of this opportunity below.

Job Description:

• 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:

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