CQV Engineer 62365

Develop and execute CQV testing documentation for utility systems within a sterile drug product manufacturing facility.

Deliver on key project milestones, including safety, schedule adherence, and high-quality documentation/electronic records for assigned equipment and utilities.

Ensure testing of utility systems complies with Good Manufacturing Practices (GMP), internal company policies, and EU/FDA regulatory standards.

Oversee commissioning of non-GMP utility systems in line with project-specific standards.

Manage deviations associated with assigned systems and equipment.

Conduct risk assessments related to CQV activities; develop mitigation strategies to address potential qualification risks.

Support Factory Acceptance Testing (FAT), and integrate outcomes into the overall qualification strategy for equipment, facilities, and utilities.

Complete all required training in a timely manner to support site compliance metrics.

Collaborate with site stakeholders, vendors, and contractors to ensure smooth project execution.

Perform field inspections, FAT/SAT participation, and walkdowns to confirm proper installation and operation of systems.

Proven ability to independently execute CQV activities from initiation through to completion.

Full lifecycle CQV project experience, including design, commissioning, qualification, and handover.

Strong background in CQV for sterile drug product manufacturing environments, including utility systems with integrated automation.

Hands-on experience with black utility systems (e.g., compressed air, plant steam, process waste, chilled water).

Excellent technical documentation and execution skills, with a strong track record of meeting project timelines.

Strong interpersonal and communication skills; ability to work effectively in cross-functional teams.

Demonstrated ability to contribute within a matrixed team environment and manage multiple priorities simultaneously.

Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.

Minimum of 5 years of CQV experience within the pharmaceutical or biotech industry, with a focus on utility systems and sterile manufacturing operations.