• Carolina, PR
    30+ days ago

    Job Description

     For Design services in the Engineering area

    WHAT MAKES YOU A FIT: 

    The Technical Part:

    • Bachelor's Degree in Engineering (Mechanical or Chemical is preferred) and (5+) years of experience within the pharmaceutical or large-scale facility design.
    • Bilingual (English & Spanish).
    • EIT or Professional Engineer (PE) license (preferred) 
    • Project Management Skills
    • Shift: Administrative and according to business needs.
    • Experience in:
      • Capital Projects delivery processes, and A/E design activities
      • Experience in GMP or regulated environments (pharma/biotech).

    The Personality Part:    

    • If you consider yourself an ingenious and creative problem-solver with an uncanny ability to lead, then this is the job for you! Sprinkle on a love for the scientific method, teamwork, and, above all else, being ethical and you just might have what it takes to take on this new challenge. Bring it on! 

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

    • Lead in the identification of the applicable Engineering Design Standards, Engineering Functional Standards, Engineering Specifications and Regulatory requirements and guidance (both internal and external).
    • Be responsible for the overall design delivery for capital project(s).
    • Coordinate all design for the Project Manager during all design phases of the project and be responsible in delivering the conceptual design review and basic design review.
    • Direct the development of the design requirements.
    • Assist in development and maintenance of the design schedule to meet the project needs.
    • Participate in the selection of the A/E firms.
    • Coordinate with A/E firms to develop earned value progress systems to measure progress by discipline (monitor work versus invoice amounts).
    • Expedite design decisions and coordinate information flow between the design team and system owners.
    • Be responsible for ensuring the design meets approved intent through interactions between the design firm, design specialists, engineering tech center disciplines, and end user/customer.
    • Be responsible for design activities and governance, resolving design-related problems.
    • Examine areas of inefficiency and develop strategies for improvement to direct the design team to meet or improve on the design hours plan.
    • Assist in the development of standard operating procedures, project delivery work instructions, and/or best practices related to design/verification and ensure they remain current with industry best practices.
    • Review and approve along with the respective Project Manager the key design project personnel (both internal and external resources).
    • Work with Engineering Tech Center resources, local engineering resources, and other key project team technical/constructability resources to address and resolve design issues.
    • Ensure replication is achieved during design when applicable.
    • Support the Project Manager for value engineering exercises efforts to maximize project opportunities.
    • Review design-related invoices prior to approval and participate in KPI reviews/assessments.
    • Participate in the selection of the verification professional services.
    • Accountable for the development of the Project Verification Plan, Traceability Matrix, and risk assessments (not necessary lead the execution).
    • Coordinate verification for the Project Manager during the verification phase of the project.
    • Accountable for the discrepancy tracking and management in the Verification phase.

    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?

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    Numbers & Facts

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

    Skills

    • Best Practicesunmatched
    • Billingunmatched
    • Biotech and Pharmaceuticalunmatched
    • Capital Projectunmatched
    • Construction Engineeringunmatched
    • Design Servicesunmatched
    • Design Verificationunmatched
    • Electronic Designunmatched
    • Engineer in Training (EIT)unmatched
    • English Languageunmatched
    • GMP (Good Manufacturing Practices)unmatched
    • Leadershipunmatched
    • Manufacturingunmatched
    • Mechanical Engineeringunmatched
    • Medical Equipmentunmatched
    • Multilingualunmatched
    • Performance Metricsunmatched
    • Problem Solving Skillsunmatched
    • Professional Engineerunmatched
    • Professional Servicesunmatched
    • Project Developmentunmatched
    • Project Planningunmatched
    • Project Trackingunmatched
    • Project/Program Managementunmatched
    • Regulatory Requirementsunmatched
    • Replication and Remote Mirroringunmatched
    • Requirements Managementunmatched
    • Risk Analysisunmatched
    • Scientific Methodunmatched
    • Spanish Languageunmatched
    • Standard Operating Procedures (SOP)unmatched
    • Standards Developmentunmatched
    • Strategic Planningunmatched
    • Team Playerunmatched
    • Technical/Engineering Designunmatched
    • Traceabilityunmatched
    • User Interface Designunmatched
    • Value Engineeringunmatched
    • Verification Plansunmatched

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