Validation Specialist

Creative Solutions Services, LLC; Richmond (VA); On-site; USD 83,000 - 124,000; Part time

Job summary

Creative Solutions Services, LLC seeks a hands-on Equipment Qualification & Process Validation Contractor to support the Enterprise Quality – Change Management & Systems organization in Richmond, Virginia. The contractor will execute IQ, OQ, and PQ for manufacturing equipment, processes, and materials in a regulated environment.

This execution-focused role receives day-to-day direction from the Manager and is measured by timely, right-first-time qualification deliverables.

Qualifications

• Bachelor's degree in a technical discipline or equivalent experience.
• 5+ years hands-on IQ/OQ/PQ and process validation 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.

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.

Skills

IQ/OQ/PQ

Process Validation

Technical Writing

GMP Documentation

eQMS (TrackWise)

MS Office / Excel

Cross-Functional Coordination

Education

Bachelor's degree in a technical discipline

Tools

TrackWise

Document Management Systems

MS Excel

Job description

Job Summary:

• 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.

Top 3 Skills:

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