Commissioning, Qualification & Validation (CQV) Engineer

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

Commissioning, Qualification & Validation (CQV) Engineer

Patients depend on therapies and devices that are safe, consistent, and ready when they are needed. This role turns that promise into evidence: equipment, utilities, and processes that are commissioned, qualified, and validated so they perform as intended, every time. You will be the person who closes the gap between design intent and a controlled, inspection-ready state—so manufacturing can start, stay compliant, and keep improving.

Performance Objectives

• Qualify new and modified equipment, facilities, and utilities so they meet user requirements and are released to production on the agreed schedule.
• Author, execute, and close commissioning, IQ, OQ, and PQ protocols with complete data, deviations resolved, and traceable conclusions.
• Build and maintain validation master plans, risk assessments, and traceability so every critical requirement is tested and justified.
• Lead change control and requalification so process or equipment changes do not weaken product quality or regulatory standing.
• Partner with Quality, Engineering, and Manufacturing to clear audit and inspection findings with documented, sustainable fixes.
• Reduce repeat deviations by turning protocol failures and nonconformances into corrective actions that hold.
• Transfer validated processes cleanly from project teams to operations, with trained owners and living documentation.

Environment & Resources

You will sit with Technical Operations / Quality Engineering and report to the CQV or Validation lead. Day to day you will work with Process Engineering, Automation, Quality Assurance, EHS, and external vendors on the plant floor and in project rooms. You will use the site quality system, document control, and standard commissioning and validation templates, with access to subject-matter reviewers and a defined project budget for protocol execution and third-party testing.

Essential Qualifications

• Bachelor’s degree in engineering, life sciences, or a related field, or equivalent practical experience.
• Hands-on CQV in a GMP or ISO 13485 environment: protocols written, executed, and approved—not only reviewed.
• Working knowledge of equipment and utility qualification, process validation, and risk-based approaches (for example, ICH Q9 thinking).
• Proven ability to investigate deviations, write clear reports, and defend conclusions to Quality and auditors.
• Comfort coordinating vendors, contractors, and cross-functional teams to a validation schedule.
• Precise technical writing and data integrity habits that stand up in an inspection.

Role Selling Points

• Work where validation directly enables therapies and devices that reach patients.
• See projects through from design review to operational handover, not a single protocol in isolation.
• Join a quality culture that treats people as individuals and expects merit, inclusion, and accountability.
• Influence how sites commission and qualify—your methods become the standard others follow.
• Grow across equipment, utilities, and process validation with engineers who own outcomes, not paperwork volume.