CQV Validation Engineer - GMP Life Sciences

Pinnaql, Inc.; Wilson, Northern (NC, KY); Hybrid; USD 85,000 - 130,000; Full time

Job summary

Validation & Engineering Group, Inc. (V&EG), a Pinnaql company, is seeking a Validation Engineer with CQV experience to support regulated life sciences facilities.

You will develop validation documentation, perform protocol execution, and ensure GMP-compliant activities across equipment, facilities, utilities, and processes. Ideal candidates will have a strong technical writing background, 3+ years in validation, and the ability to collaborate with Engineering, QA, Manufacturing, and

Qualifications

• Bachelor's degree in Engineering, Science, or related technical discipline.
• 3+ years of validation, qualification, commissioning, or CQV experience in regulated life sciences.
• Experience in pharmaceutical, biotechnology, medical device, or GMP-regulated industries.
• Strong GMP and validation principles.
• Experience with risk-based validation methodologies.
• Strong technical writing and documentation skills.
• Ability to interpret engineering drawings and specifications.
• Strong organizational and project management skills.
• Ability to work independently and in teams.

Responsibilities

• Execute CQV activities for pharmaceutical, biotechnology, medical device, or other regulated life sciences facilities.
• Develop, review, and execute validation documentation, including: Validation Plans, URS, Risk Assessments, Design/Functional Specifications, IQ/OQ/PQ protocols and reports, Traceability Matrices, Summary Reports.
• Support qualification of equipment, facilities, utilities, and manufacturing systems.
• Perform protocol execution, field verification, data collection, and review of qualification results.
• Ensure validation activities are performed in compliance with GMP, FDA, EU GMP, and applicable industry standards.
• Participate in FMEA/risk assessments and apply a risk-based approach to validation activities.
• Support deviations, investigations, CAPA, and change control activities associated with validation projects.
• Review engineering and technical documentation to ensure validation requirements are adequately addressed.
• Collaborate with Engineering, Quality Assurance, Manufacturing, Automation, Facilities, and other project stakeholders.
• Track validation deliverables, schedules, open items, and project milestones.
• Support commissioning activities and transition from commissioning into formal qualification.
• Ensure validation documentation is complete, accurate, and audit-ready.
• Participate in client meetings, project status meetings, and technical reviews.
• Provide technical support during regulatory or client inspections, as required.

Skills

Technical writing

Documentation

Collaboration

Attention to detail

Project management

Education

Bachelor's degree in Engineering/Science

Job description

Validation & Engineering Group, Inc. (V&EG), a Pinnaql company, is seeking a Validation Engineer with CQV experience to support regulated life sciences facilities.

You will develop validation documentation, perform protocol execution, and ensure GMP-compliant activities across equipment, facilities, utilities, and processes. Ideal candidates will have a strong technical writing background, 3+ years in validation, and the ability to collaborate with Engineering, QA, Manufacturing, and