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C&Q Executer

  • FITS, LLC
  • Juncos, Puerto Rico
  • $45,000 – $60,000

For C&Q services in the Business Operations area.

WHAT MAKES YOU A FIT:

The Technical Part:

  • Bachelor’s Degree in Science, or Engineering field with at least2 yearsof proven experience in commissioning and qualification processes, protocol generation and execution.
  • Bilingual (Spanish and English.)
  • Shift: Administrative and according to business needs.
  • Experience in:
    • Executing commissioning and qualification activities in the field.
    • Generating protocols and technical documents in line with current industry standards and regulatory requirements (e.g., cGMP, FDA, ISPE/ASTM E2500).
    • Reporting deviations during tests, proposing corrective actions, and participating in the implementation and verification of corrections.
    • Planning and coordinating resources, measurement/calibration equipment, and tooling needed for tests.

The Personality Part:

  • Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients and team members. In other words, being a customer service pro is one your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to take on this new challenge?

AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)

  • Support the planning and execution of commissioning, qualification, and validation (CQV) activities.
  • Develop qualification protocols
  • Support and influence effectively to ensure all necessary Commissioning, Qualification, and Validation (CQV) activities are completed on time and according to the validation program.
  • Developing validation status reports.
  • Participate in and support Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) of new equipment.
  • Record results legibly and verifiably, following data integrity principles (ALCOA) where applicable.
  • Report deviations during tests, propose corrective actions, and participate in the implementation and verification of corrections.
  • Plan and coordinate resources, measurement/calibration equipment, and tooling needed for tests.
  • Comply with site safety rules, permits, and policies while on site.

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?

Skills

  • Commissioning and Qualification (C&Q)
  • Protocol Generation
  • cGMP compliance
  • FDA Regulations
  • ISPE/ASTM E2500
  • Deviation Management
  • Bilingual (Spanish/English)

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