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C&Q Lead

Flexible & Integrated Technical Services, LLC · fitspr.com
BarcelonetaLead / ManagerContract
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Details

Found
15 d ago · posted 2026-10-22
Location
Barceloneta

Full description

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. AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) • 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. WHO WE ARE: We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS! Are you the Next Piece? ​

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