Manufacturing Engineer I - 158

Flexible & Integrated Technical Services, LLC
  • Villalba, PR
    30+ days ago

    Job Description

    For engineering services in the Manufacturing area.

    WHAT MAKES YOU A FIT: 

    The Technical Part:

    • Bachelor’s Degree in Engineering and two (2) years of exposure within the Medical Devices Industry.
    • Bilingual: Spanish and English
    • Soft Skills: Excellent teamwork skills
    • Shift: 1st, and according to business needs. 
    • Experience in: 
      • Validation of manufacturing processes and equipment
      • CSV Equipment Validation.
      • Cross-functional team collaboration

    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)

    •  Experience in performing software and computer equipment validation.  
    • Highly desirable previous experience executing CSV validation of Equipment Controller in a Medtronic facility.
    • Familiar with validation requirements in regulated industry.  
    • Capable of developing software qualification protocols and reports.  
    • Must be capable of working independently with general supervision.  
    • Must collaborate with engineering process owners in development and execution of protocols.  
    • Must negotiate with operations and engineering process owners maintenance windows to execute protocols.
    • Perform CSV on computers that are reserved for FW Pulse and require the use of a revision of an EC or EF that is different from the one currently in use in production.
    • Prepare CSV protocols, execute them, and prepare reports that demonstrate that the new computer will function exactly as intended. 

    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?

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    Numbers & Facts

    LocationVillalba, PR
    Websitehttp://www.fitspr.com

    Skills

    • Biotech and Pharmaceuticalunmatched
    • Computer Softwareunmatched
    • Construction Engineeringunmatched
    • Cross-Functionalunmatched
    • Customer Support/Serviceunmatched
    • English Languageunmatched
    • Equipment Validationunmatched
    • Financial Controlunmatched
    • Manufacturingunmatched
    • Manufacturing Engineeringunmatched
    • Manufacturing/Industrial Processesunmatched
    • Medical Equipmentunmatched
    • Multilingualunmatched
    • Negotiation Skillsunmatched
    • Operations Processesunmatched
    • Reporting Skillsunmatched
    • Requirements Validation/Verificationunmatched
    • Software Developmentunmatched
    • Spanish Languageunmatched
    • System Validationunmatched
    • Team Playerunmatched

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