CQV Lead

Barceloneta, Puerto Rico
Contracted
Pharmaceutical
Experienced

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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