CQV Project Manager – GMP Validation (Mid-Level)

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

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.