CQV Engineer

Job Title: CQV Engineer Location: Holly Springs, NC Experience Required: 5+ years Employment Type: 12+ months Contract

Job Summary

We’re looking for a skilled and motivated CQV Engineer to support the commissioning, qualification, and validation of pharmaceutical and biotechnology facilities. This role involves ensuring all systems, equipment, and processes operate in full compliance with regulatory standards and project requirements. The ideal candidate has a strong technical foundation in CQV practices, hands-on experience with validation of GMP equipment and utilities, and a solid understanding of global regulatory expectations.

Key Responsibilities

CQV Execution: Develop, review, and execute commissioning, qualification, and validation (CQV) protocols for new and existing pharmaceutical manufacturing systems, utilities, and equipment.

Project Leadership: Lead CQV project activities from planning to completion, coordinating efforts with internal engineering, QA, validation, and external vendors or contractors.

Documentation: Prepare and maintain validation documentation including URS, DQ, FAT/SAT, IQ, OQ, and PQ protocols and reports in accordance with internal SOPs and regulatory requirements.

Risk Management: Conduct risk assessments, impact assessments, and gap analyses to identify compliance risks and implement effective mitigation strategies.

Regulatory Compliance: Ensure all CQV activities comply with applicable standards and regulations including FDA, EMA, ICH, and cGMP guidelines.

Continuous Improvement: Identify and implement process improvements to enhance CQV efficiency, documentation quality, and project delivery timelines.

Technical Support: Troubleshoot and resolve issues related to equipment qualification, system integration, and process validation.

Training & Mentorship: Support training and development of junior CQV engineers and technicians to build technical capability across the team.

Stakeholder Engagement: Participate in client and project team meetings, provide technical updates, and ensure alignment with project milestones and deliverables.

Qualifications

• Bachelor’s degree in Engineering, Biotechnology, or a related technical discipline.

• Minimum 5 years of hands-on experience in CQV within the pharmaceutical or biotech industry.

• Strong knowledge of cGMP , FDA , EMA , and ICH guidelines.

• Proven experience with qualification of process equipment, utilities (WFI, Clean Steam, HVAC), and automation systems.

• Proficient in protocol development, execution, and deviation management.

• Excellent project coordination, time management, and organizational skills.

• Strong written and verbal communication abilities.

• Able to work independently and collaboratively in a fast-paced, regulated environment.

• Willingness to travel occasionally to client or project sites as required.