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For Validation services in the Engineering & Manufacturing areas.

About Flexible & Integrated Technical Services, LLC

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?

  • 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

  • EO/EtO sterilization processes and validation activities (preferred) Working with external suppliers and supplier qualification projects (preferred) GMP & GDP The Personality Part: Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients and team members.
  • AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) Development and execution support of validation protocols and reports.
  • Change control support (CRs, TRs, VPs, protocol execution, evidence compilation, and closure activities).
  • Qualification and operational readiness activities across systems, processes, and infrastructure.
  • Cross-functional coordination with Engineering, Quality, Operations, Planning, Supply Chain, and external suppliers.
  • Support for SOP updates, training, UAT activities, implementation readiness, and post-implementation support.
  • Technical support for supplier qualification and validation activities.

Requirements

  • The Technical Part: Bachelor's Degree in Engineering and previous exposure to validation quality activities within the Pharmaceutical or Medical Devices industry.
  • Bilingual, Spanish and English (good communication) Shift: Administrative & according to business needs Experience in: Protocol development, execution, investigations, and technical documentation.
  • Minitab, JMP, or similar statistical analysis tools.

Benefits

  • In other words, being a customer service pro is one your (many) talents.