Flexible & Integrated Technical Services, LLC

Validation Engineer - 106

Medical Devices - Villalba, PR, Puerto Rico - Contracted

For validation services in the Manufacturing area.

WHAT MAKES YOU A FIT: 

The Technical Part:

  • Bachelor’s Degree in Engineering and three (3) years of experience within the Medical Devices Industry.
  • Bilingual: Spanish and English
  • Soft Skills: Writing and communication skills
  • Shift: 1st and according to business needs. 
  • Experience in: 
    • Validation documentation (IQ).
    • The evaluation, qualification, and documentation of computerized systems and manufacturing processes
    • Troubleshooting Windows 10.
    • SDLC experience 

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)

  • Evaluate the impact of validated computerized systems on existing work instructions and processes.
  • Prepare and execute computer system validation protocols and generate comprehensive reports.
  • Develop and maintain Installation Qualification (IQ) documentation.
  • Collaborate with process owners to implement changes to work instructions and ensure compliance. 
  • Inspect machinery, equipment, and tools to verify performance and initiate corrective actions.
  • Ensure adherence to company procedures, quality system regulations, and industry standards.
  • Apply technical expertise and knowledge of Medtronic’s engineering practices to optimize equipment and manufacturing techniques.
  • Organize and track project progress, maintaining detailed documentation and status updates.
  • Contribute to cross-functional projects and support milestone completion. 
  • Communicate effectively with internal stakeholders to share updates, gather input, and support decision-making.

WHO WE ARE:

We are a Service Provider company different from the rest. We pride ourselves on 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: Validation Engineer - 106
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