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Validation Specialist

PublishedPublished: 6/14/2022
Technology

Job Description

Job Title: Validation Specialist

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Duration: 06 Months

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Shift: 1st Shift

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Location: Richmond, VA 23234

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Pay Rate: $57.97/Hour on W2

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Job Summary:

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  • We are seeking a hands-on Equipment Qualification & Process Validation Contractor to support the Enterprise Quality – Change Management & Systems organization.
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  • 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.
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  • This is an execution-focused role, with day-to-day direction from the Manager.
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  • Success will be measured by the timely, accurate, and right-first-time completion of qualification deliverables.
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Key Responsibilities:

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  • Execute and close IQ/OQ/PQ protocols for manufacturing equipment and systems.
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  • Author protocols, qualification reports, and GMP-compliant documentation.
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  • Document deviations/discrepancies and maintain full record traceability.
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  • Coordinate qualification activities with Manufacturing, Engineering, Quality, and Project teams.
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  • Support change control, documentation remediation, and record management.
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  • Execute qualification activities on the factory floor around production schedules.
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Qualifications:

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  • Bachelor's degree in a technical discipline or equivalent experience.
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  • 5+ years of hands-on IQ/OQ/PQ and process validation experience in GMP or regulated manufacturing.
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  • Experience with protocol writing, execution, reports, deviations, and traceability.
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  • Proficiency with eQMS (TrackWise or similar), document management systems, and MS Office/Excel.
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  • CQE, CQA, ASQ, or similar certification preferred.
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Top 3 Skills:

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  • IQ/OQ/PQ & Process Validation
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  • Technical Writing & GMP Documentation
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  • Cross-Functional Coordination & Factory-Floor Execution
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