CQV Engineer III (Life Sciences)

Location: Raleigh, NC, USA; full-time role with travel of 50% or more as needed.

Company

hirify.global provides engineering, architecture, construction, and consulting solutions for the global life sciences and food and beverage industries.

What you will do

• Define client requirements and develop project-specific commissioning, qualification, and validation plans.
• Review and approve CQV strategies for equipment and utility systems, including process equipment, clean utilities, HVAC, WFI, CIP/SIP, nitrogen, and compressed air.
• Lead or support field execution, including FAT/SAT, test protocols, qualification activities, and independent verification of deliverables.
• Coordinate CQV activities with engineering, construction, quality assurance, and external resources.
• Manage CQV schedules, project milestones, progress reporting, risks, and regulatory compliance.
• Mentor junior engineers and support lessons learned and continuous improvement initiatives.

Requirements

• Master’s degree in Engineering, Life Sciences, or a related field with at least 5 years of CQV experience, or bachelor’s degree in Engineering, Architecture, or Construction Management with 5+ years of CQV experience in the life sciences industry.
• Experience commissioning and qualifying life sciences equipment and utility systems.
• Working knowledge of cGMP, FDA, EU, and ISPE guidelines, including ISPE Baseline Guide 5 and risk-based CQV approaches.
• Familiarity with URS, FAT, SAT, IQ, OQ, and PQ documentation and execution.
• Proficiency in risk assessment, root cause analysis, continuous improvement, technical writing, and document review.
• Strong communication, presentation, leadership, and cross-functional coordination skills; willingness to travel 50% or more.

Culture & Benefits

• Collaborative work across engineering, quality assurance, construction, and project teams.
• Opportunities to mentor colleagues and contribute to CQV best practices and continuous improvement.
• Competitive benefits package designed to support individual and family needs.
• Equal opportunity employment and a commitment to a diverse workforce.