Validation Specialist - 106

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profile Job Location:

Villalba - USA

profile Monthly Salary: Not Disclosed
Posted on: 30+ days ago
Vacancies: 1 Vacancy

Job Summary

For validation services in the Manufacturing area.

WHAT MAKES YOU A FIT:

The Technical Part:

  • Bachelors Degree in Engineering and three (3)years of experiencewithin 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 other words being a customer service pro is one of your (many) talents. Being the Piece means youre 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.
  • Developand maintainInstallation 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 Medtronics 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 companydifferent from the rest. We pride ourselves on how we treat the most important piece of our companys 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 industryclients with top-notch quality talent.Were FITS!

Are you the Next Piece


Required Experience:

Manager

For validation services in the Manufacturing area.WHAT MAKES YOU A FIT:The Technical Part:Bachelors Degree in Engineering and three (3)years of experiencewithin the Medical Devices Industry.Bilingual: Spanish and EnglishSoft Skills: Writing and communication skillsShift: 1st and according to busines...
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Key Skills

  • Python
  • SOC
  • Debugging
  • C/C++
  • FDA Regulations
  • Minitab
  • Technical Writing
  • GAMP
  • OS Kernels
  • Perl
  • cGMP
  • Manufacturing

About Company

Company Logo

F I T S, LLC FLEXIBLE & INTEGRATED TECHNICAL SERVICES

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