Flexible & Integrated Technical Services, LLC

Project/Validation Engineer

Medical Device - Arecibo, PR, Puerto Rico - Contracted

For Validation services in the Engineering area. 

WHAT MAKES YOU A FIT: 

The Technical Part:

  • Bachelor’s Degree and or an equivalent of three (3) years of experience in Industrial and Construction projects within the regulated industry. 
  • Bilingual (Spanish and English). 
  • Good organizational and problem-solving skills. 
  • Shift: First (Monday-Friday) & according to business needs. 
  • Experience in:
    • Process Validation and Development.
    • FDA, GMP, and ISO guidelines.
    • Statistical techniques (DOE, SPC).
    • Computer software knowledge (Microsoft Word, Excel, Power Point).

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 of 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 Be The Piece?

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

  • Develops, manages, and executes cost improvement, product/process, and technology transfer projects. 
  • Prepare operational qualification assessments to support that validated critical operating parameters are within qualified parameters. 
  • Generate and execute validation protocols (IQ, OQ, PQ, TMV, TQF, Process Characterization and Process Validation based on equipment capabilities. 
  • Conduct process equipment installation/operational/performance qualification studies to test their functionality . 
  • Support New Products Introduction (NPI) and Process transfer activities in a regulated manufacturing environment.
  • Other duties as assigned. 

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?

Apply: Project/Validation Engineer
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