• Juncos, 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 Mechanical or Engineering and five (5) 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: 
      • Equipment Relocation, Installation & Decommissioning
      • Process Validation
      • Manufacturing Process & Facility Change Management 

    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)

    • Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.
    • Designs arrangement of machines within plant facilities to ensure most efficient and productive layout.
    • Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance.
    • Adapts machine or equipment design to factory and production conditions. May incorporate inspection and test requirements into the production plan.
    • Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
    • Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques.
    • Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
    • Ensures processes and procedures are in compliance with regulations.
    • Experience executing manufacturing equipment moves, installations, commissioning, startup, and decommissioning activities.
    • Knowledge of facility utilities, equipment integration, and manufacturing readiness activities.
    • Strong experience with equipment qualification (IQ/CSV/OQ/PQ), process validation, cleaning validation, and cleanroom qualification.
    • Familiarity with GMP requirements, change control, risk assessments, and maintaining validated state following equipment or facility changes
    • Experience supporting manufacturing layout changes, facility modifications, material and personnel flow assessments.​​
    • Ability to evaluate facility, utility, and environmental requirements for regulated manufacturing operations.

    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

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

    Skills

    • Biotech and Pharmaceuticalunmatched
    • Change Controlunmatched
    • Change Managementunmatched
    • Cleanroomunmatched
    • Commissioningunmatched
    • Construction Engineeringunmatched
    • Corrective Actionunmatched
    • Customer Support/Serviceunmatched
    • Develop Methodologiesunmatched
    • English Languageunmatched
    • Environmental Regulationsunmatched
    • Facilities Managementunmatched
    • GMP (Good Manufacturing Practices)unmatched
    • Machiningunmatched
    • Manufacturingunmatched
    • Manufacturing Assemblyunmatched
    • Manufacturing Engineeringunmatched
    • Manufacturing Equipmentunmatched
    • Manufacturing Methodsunmatched
    • Manufacturing Operationsunmatched
    • Manufacturing/Industrial Processesunmatched
    • Mechanical Engineeringunmatched
    • Medical Equipmentunmatched
    • Multilingualunmatched
    • Operations Processesunmatched
    • People Managementunmatched
    • Performance Managementunmatched
    • Plant Layout and Designunmatched
    • Process Developmentunmatched
    • Process Validationunmatched
    • Production Planningunmatched
    • Regulatory Complianceunmatched
    • Risk Analysisunmatched
    • Risk Managementunmatched
    • Spanish Languageunmatched
    • Startupunmatched
    • Statistical Process Controlunmatched
    • Team Playerunmatched
    • Test Requirementsunmatched

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