We are seeking an experienced Senior CQV Engineer with a strong engineering background to support engineering projects with a focus on facilities and utilities-related capital projects at a large biopharmaceutical manufacturing facility
Working as part of the Global Capital Projects (CapEx) team, this individual will be responsible for independently managing commissioning, qualification, and validation (CQV) activities throughout the project lifecycle, from initial assessment and strategy development through execution and project closeout.
The ideal candidate will have extensive hands-on experience with GMP facility and utility systems, and a demonstrated ability to manage projects from start to finish. This includes assessing technical challenges, developing appropriate validation strategies, coordinating engineering and quality activities, managing change controls, and driving execution to completion.
Key Responsibilities
• Lead and manage general CQV activities with an initial focus on facility and utility capital projects.
• Take ownership of assigned projects throughout the full lifecycle, from initial technical assessment and validation strategy development through execution, documentation, and closeout.
• Assess project requirements, identify technical challenges, and develop practical CQV strategies to address equipment, system, or facility-related issues.
• Develop, coordinate, and manage project schedules, CQV execution plans, milestones, and resource priorities.
• Initiate, coordinate, and manage GMP change controls, including technical impact assessments, documentation, implementation, and closure.
• Review and interpret engineering drawings, including P&IDs, to evaluate system configurations, identify technical requirements, and support qualification activities.
• Coordinate with engineering, facilities, quality, operations, and project management teams to ensure successful execution of project objectives.
• Oversee, review, and support field commissioning and qualification activities, ensuring compliance with applicable GMP requirements and site procedures.
• Identify and troubleshoot technical or project-related issues, coordinate corrective actions, and drive timely resolution.
• Provide technical direction and coordination to other CQV resources and project stakeholders.
• Maintain accurate project and validation documentation, communicate progress, and ensure activities remain aligned with established schedules and deliverables.
Experience/Skills
• Significant experience in commissioning, qualification, and validation within GMP-regulated pharmaceutical or biotechnology manufacturing environments.
• Strong engineering background with demonstrated experience supporting facilities and utility systems.
• Direct experience with pharmaceutical water systems, including WPU and WFI, and associated commissioning and qualification activities.
• Proven ability to independently manage CQV projects from initial planning and validation strategy development through execution and closeout.
• Experience developing and managing project schedules, coordinating resources, and driving project deliverables.
• Demonstrated experience managing GMP change controls and associated technical documentation.
• Ability to assess technical problems, develop appropriate validation strategies, and independently execute solutions.
• Experience collaborating with cross-functional engineering, facilities, quality, and operations teams.
• Strong organizational, communication, technical problem-solving, and project management skills.
• Self-motivated, results-oriented approach with the ability to take ownership of projects and work effectively with minimal supervision.
