CQV Project Manager

Arcadis; Cary (NC); On-site; USD 90,000 - 140,000; Full time

Job summary

Arcadis is a global EPCM firm seeking a Mid-Level CQV Project Manager in Cary, NC. You will lead CQV projects, coordinate teams, manage schedules and budgets, and ensure safe, compliant delivery for clients in life sciences and tech sectors.

The role involves developing CQV lifecycle documentation, coordinating with engineers and stakeholders, and traveling to client sites as required. Strong GMP and ISPE knowledge is essential.

Qualifications

• Proven ability to lead CQV projects and manage client relationships.
• Experience in FDA-regulated manufacturing environments.
• Knowledge of validation lifecycle documents (URS, FRS, DDS, DQ, IQ, OQ, FAT, SAT).
• Strong understanding of cGMP, GEP, ISPE guidance, ASTM E2500.

Responsibilities

• Lead day-to-day execution of assigned CQV projects.
• Coordinate engineers, contractors, vendors, and client stakeholders.
• Track schedules, budgets, forecasts, risks, and action items.
• Lead routine client meetings and provide project status updates.
• Escalate risks to senior leadership as appropriate.
• Review design documentation for GMP compliance.
• Participate in design reviews and support DQ activities.
• Develop and execute commissioning and qualification documentation.
• Support FATs, SATs, commissioning, IQ/OQ execution, and turnover activities.
• Manage deviations, punch list items, and retesting activities.

Skills

Communication

Organization

Leadership

GMP familiarity

CQV experience

Education

Bachelor's degree in Engineering or related technical discipline

Tools

Microsoft Office

Bluebeam

Microsoft Project

Kneat

Job description

Our Cary, NC CQV team is growing. We are looking to add additional, Mid-Level CQV Project Manager to the team. The CQV Project Manager leads small to mid-sized commissioning, qualification, and validation (CQV) projects, ensuring safe, compliant, on-time, and within-budget delivery. This client-facing role coordinates project execution, manages stakeholder communication, and oversees project schedules, budgets, and resource planning.

Responsibilities include developing, reviewing, and coordinating CQV lifecycle documentation such as Validation Plans, Commissioning Plans, URS, FRS, DQ, IQ/OQ protocols, commissioning protocols, traceability matrices, and summary reports. The PM typically manages teams of 2-8 CQV Engineers, depending on project scope and complexity, while promoting adherence to company and client EHS standards

Key Responsibilities

• Lead day-to-day execution of assigned CQV projects.
• Coordinate engineers, contractors, vendors, and client stakeholders.
• Track schedules, budgets, forecasts, risks, and action items.
• Lead routine client meetings and provide project status updates.
• Escalate technical or schedule risks to senior leadership as appropriate.
• Review design documentation for GMP compliance.
• Participate in design reviews and support DQ activities.
• Develop and execute commissioning and qualification documentation using established company standards.
• Support FATs, SATs, commissioning, IQ/OQ execution, and turnover activities.
• Manage deviations, punch list items, and retesting activities.
• Willingness to travel to client sites is required.

Skills & Qualifications

• Bachelor's degree in Engineering or related technical discipline preferred.
• 5–8 years of CQV experience or equivalent combination of education and experience.
• Strong communication, organization, and leadership skills.
• Proficiency with Microsoft Office, Bluebeam, Microsoft Project, Kneat, and various industry specific platforms.
• Experience working in FDA-regulated manufacturing environments.
• Strong working knowledge of cGMP regulations, Good Engineering Practices (GEP), ISPE guidance, and ASTM E2500.
• Working knowledge of cleanrooms, utilities, process equipment, automation, and facility systems.
• Familiarity with validation lifecycle documents including URS, FRS, DDS, DQ, IQ, OQ, FAT, SAT, and commissioning documentation.

The Company

Arcadis is a global EPCM firm offering full-service solutions within the Life Sciences (pharmaceutical, biotechnology, and medical technology) and Advanced Technology (semiconductor, data center, and solar) industries. Arcadis is dedicated to delivering successful projects with a ‘client-first’ mentality and personal touch across a range of market sectors: Project and Program Management, Procurement, Design, Construction Management, Health and Safety Management, Commissioning, Qualification, and Start-up.

Arcadis is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. Arcadis does not discriminate in employment opportunities or practices on the basis of: race, color, religion, gender, national origin, age, sexual orientation, gender identity, disability, veteran status or any other characteristic protected by country, regional or local law.