Quality Engineer – Equipment Qualification
Integration International Inc. · Richmond, Virginia, United States
FULL TIMEpermanent
Job Description
Job Title: Quality Engineer – Equipment QualificationDuration: 06 MonthsShift : 1st ShiftLocation: Richmond, VA 23234Pay Rate: $57.97/Hour on W2Job 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 ManagerThis 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. xzbcwsv Cross-functional coordination and self-directed execution in a live factory environment.
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 ManagerThis 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. xzbcwsv Cross-functional coordination and self-directed execution in a live factory environment.
Details
| Company | Integration International Inc. |
| Location | Richmond, Virginia, United States |
| Type | FULL TIME |
| Niche | general |
| Experience | permanent |
