CQV Project Manager

Overview

The CQV Project Manager is responsible for leading and coordinating all commissioning, qualification, and validation (CQV) activities within an assigned project area on a large-scale greenfield pharmaceutical manufacturing project. This role serves as the primary liaison between execution teams and program leadership, ensuring CQV activities are planned, executed, and delivered in alignment with project timelines, regulatory requirements, and overall program strategy.

The position drives day-to-day execution, system readiness, and performance reporting while fostering a strong culture of safety, quality, and accountability. This role is particularly critical in supporting first-time facility startup, including complex systems such as tank farms and solvent handling infrastructure in support of drug discovery and clinical manufacturing.

Job Responsibilities

• Lead and coordinate all project-level CQV activities within a greenfield manufacturing environment, serving as the primary point of contact for program leadership.
• Develop and execute CQV strategies, plans, and schedules to support project milestones, startup readiness, and regulatory compliance.
• Oversee daily CQV execution, ensuring alignment with procedures, validation strategies, and industry standards.
• Coordinate cross-functional activities with construction, mechanical, automation, and process teams to support pre-commissioning efforts (e.g., calibration, utility startup, system setup).
• Drive commissioning and qualification of critical systems, including tank farm operations and solvent handling/management systems.
• Support and coordinate Factory Acceptance Testing (FAT) activities with vendors and ensure outcomes are incorporated into execution plans.
• Lead system handovers to end users, ensuring operational readiness for clinical manufacturing and drug development activities.
• Provide regular reporting on progress, risks, schedule, and resource planning, including look-ahead forecasts and critical path updates.
• Identify risks and issues proactively, implementing mitigation strategies to maintain project timelines.

Job Qualifications

• Bachelor’s degree in Engineering, Science, or a related technical field.
• 3 years of experience in commissioning, qualification, and validation (CQV) within pharmaceutical, biotech, or other regulated environments.
• Demonstrated experience supporting greenfield or large-scale capital projects.
• Hands-on experience with tank farm systems, solvent handling, or solvent management in a GMP environment.
• Strong knowledge of GMP, FDA regulations, and CQV/validation lifecycle practices.
• Proven experience leading or coordinating CQV activities at a system or project level.
• Experience supporting facility startup and readiness for clinical manufacturing or drug development environments is a plus.
• Ability to manage multiple workstreams in a fast-paced, complex project environment.
• Strong leadership, communication, and cross-functional coordination skills.