CQV Engineer: Drive GMP Validation to Production

ProQualityNetwork; Wilson (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

ProQualityNetwork is seeking a CQV Engineer to ensure commissioning, qualification, and validation of equipment, utilities, and processes in a GMP/ISO 13485 environment. This role closes gaps between design intent and controlled, inspection-ready state to enable compliant manufacturing.

You will author and execute IQ/OQ/PQ protocols, build validation master plans, manage risk assessments, and coordinate cross-functional teams to meet project timelines and regulatory expectations.

Qualifications

• Bachelor’s degree in engineering, life sciences, or related field.
• Hands-on CQV experience in GMP or ISO 13485 environments.
• Experience with equipment/utility qualification, process validation, and risk-based approaches (e.g., ICH Q9).
• Proven ability to investigate deviations, write clear reports, and defend conclusions to Quality and auditors.
• Ability to coordinate vendors, contractors, and cross-functional teams on a validation schedule.
• Precise technical writing and data integrity habits suitable for inspection.

Responsibilities

• Qualify new and modified equipment, facilities, and utilities per user requirements and release to production on schedule.
• Author, execute, and close IQ, OQ, and PQ protocols with complete data and traceable conclusions.
• Build and maintain validation master plans, risk assessments, and traceability.
• Lead change control and requalification to maintain product quality and regulatory standing.
• Partner with Quality, Engineering, and Manufacturing to clear audit findings with sustainable fixes.
• Reduce repeat deviations by turning protocol failures and nonconformances into corrective actions.
• Transfer validated processes from project teams to operations with trained owners and living documentation.

Education

Bachelor’s degree in engineering, life sciences, or related field

Job description

ProQualityNetwork is seeking a CQV Engineer to ensure commissioning, qualification, and validation of equipment, utilities, and processes in a GMP/ISO 13485 environment. This role closes gaps between design intent and controlled, inspection-ready state to enable compliant manufacturing.

You will author and execute IQ/OQ/PQ protocols, build validation master plans, manage risk assessments, and coordinate cross-functional teams to meet project timelines and regulatory expectations.