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CQV Lead

  1. North America, United States
Barceloneta
  1. Contract
Competitive
  1. Commissioning, Qualification and Validation
38089
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CQV Lead - Puerto Rico - 12-month contract

We are recruiting on behalf of a leading global pharmaceutical client based in the surroundings of Barceloneta. Due to a large capital investment and multiple projects on site, the client is looking for a CQV Lead to join their team.

Responsibilities:
  • Act as the main point of contact for the C&Q Program Lead, supporting the delivery of commissioning and qualification activities across the Node.
  • Develop and implement robust C&Q strategies, plans, and schedules to meet regulatory requirements and project timelines.
  • Ensure all C&Q activities within the Node follow established procedures and program strategies.
  • Identify and drive improvements in C&Q practices to enhance efficiency while maintaining compliance.
  • Provide regular updates to program leadership on progress, risks, and issues.
  • Coordinate Factory Acceptance Tests (FATs) with vendors and construction managers.
  • Support day-to-day C&Q activities, including reviewing mechanical completion (MC) acceptance and coordinating pre-commissioning tasks such as:
    • Utility priming
    • Instrument calibration
    • Automation downloads
    • Consumable installation (e.g. filter cartridges)
    • VFD setup
  • Assist with closing out punch list items in collaboration with C&Q Firms and SWAT Teams.
  • Liaise with other Node Leads to ensure consistency and alignment across the program.
  • Manage utility demands and temporary power needs (e.g. steam, water).
  • Coordinate wastewater discharge and monitor load on drains and sumps.
  • Support lockout/tagout (LOTO) processes with the mechanical team.
  • Lead or support system handovers to the User team.
  • Track and report key metrics to the C&Q Program Lead, including:
    • Change management
    • Progress and metric tracking
    • 2–4 week look-ahead planning
    • Critical path analysis
    • Resource planning
  • Champion a strong safety culture, ensuring all C&Q activities meet site safety standards and industry best practices.

Qualifications & Skills:
  • Bachelor's degree in engineering, science, or a related field.
  • Experience in commissioning and qualification, ideally within pharmaceutical or biotech environments.
  • Deep understanding of regulatory requirements and industry standards for C&Q.
  • Strong leadership and coordination skills, with the ability to manage multiple activities across teams.
  • Excellent problem-solving and analytical abilities, with a proactive approach to continuous improvement.
  • Clear and confident communicator, capable of reporting effectively to senior stakeholders.
  • Committed to maintaining a safe working environment and enforcing safety compliance throughout all project phases.


If this role is of interest, please apply now!

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