C&Q Lead

For CQV support in the Global Engineering area.

About Flexible & Integrated Technical Services, LLC

• 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? ​

Responsibilities

• 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.
• 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.
• 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.

Requirements

• 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.
• Coordinating or leading C&Q activities on pharmaceutical capital projects.