CQV Lead

For CQV support in the Global Engineering area. 

WHAT MAKES YOU A FIT: 
The Technical Part:

• Bachelor’s Degree in Life Science or Engineering, and seven years (7+) of experience in commissioning, qualification, validation, engineering, or related discipline within the pharmaceutical, biotechnology, medical device, or other regulated industry.
• Bilingual (Spanish & English)
• Strong communication, organizational, and problem-solving skills.
• Ability to manage multiple priorities and work effectively in a fast-paced project environment.
• Experience in:
• Coordinating or leading C&Q activities on pharmaceutical capital projects.
• Facilities, clean utilities, process utilities, HVAC, water systems, process equipment, manufacturing systems, or laboratory systems.
• developing, reviewing, and executing C&Q documentation and protocols.
• supporting deviations, change controls, non-conformances, and corrective actions.
• engineering contractors, equipment vendors, construction teams, and site operations.

• Lead and coordinate day-to-day C&Q activities for assigned systems and project areas.
• Coordinate C&Q engineers, subject matter experts, contractors, and equipment vendors.
• Support the C&Q Manager in developing and maintaining C&Q plans, schedules, resource requirements, and deliverables.
• Ensure C&Q activities are incorporated into the integrated project schedule and delivered in line with project milestones.
• Apply risk-based commissioning and qualification principles to assigned systems.
• Coordinate the preparation, review, and execution of commissioning tests, qualification protocols, reports, and turnover documentation.
• Review C&Q documentation for completeness, accuracy, traceability, and compliance.
• Support the investigation and resolution of deviations, non-conformances, test failures, punch-list items, and other C&Q issues.
• Coordinate with engineering, construction, quality, operations, maintenance, automation, project controls, and external vendors.
• Provide regular updates on C&Q progress, risks, issues, and schedule performance.
• Support factory acceptance testing, site acceptance testing, system turnover, operational readiness, and project handover activities.
• Support audits, inspections, and project readiness reviews as required.
• Ensure all activities are performed in accordance with applicable health, safety, environmental, quality, and GMP requirements.

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