CQV Validation Engineer – Life Sciences (GMP)

Pinnaql; Wilson (NC); On-site; USD 85,000 - 120,000; Full time

Job summary

Validation & Engineering Group, Inc. is seeking an experienced Validation Engineer to lead CQV activities in life sciences facilities, ensuring compliant commissioning, qualification, and validation of systems and processes.

The role requires hands-on CQV execution, documentation development, and the ability to work with Engineering, Quality, Manufacturing, Automation, and Project Management teams to deliver validated facilities and equipment in line with GMP, FDA, and EU regulations.

Qualifications

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

Responsibilities

• Execute CQV activities for life sciences facilities and systems.
• Develop, review, and execute validation documentation (IQ/OQ/PQ, design specs, risk assessments).
• Qualify equipment, facilities, utilities, and manufacturing systems.
• Perform protocol execution, data collection, and review qualification results.
• Ensure validation activities comply with GMP, FDA, EU GMP, and industry standards.
• Support deviations, CAPA, and change control.
• Collaborate with Engineering, QA, Manufacturing, Automation, Facilities, and project stakeholders.
• Track deliverables, schedules, and milestones.
• Assist in transitioning commissioning to formal qualification.
• Provide audit-ready documentation for inspections.

Job description

Validation & Engineering Group, Inc. is seeking an experienced Validation Engineer to lead CQV activities in life sciences facilities, ensuring compliant commissioning, qualification, and validation of systems and processes.

The role requires hands-on CQV execution, documentation development, and the ability to work with Engineering, Quality, Manufacturing, Automation, and Project Management teams to deliver validated facilities and equipment in line with GMP, FDA, and EU regulations.