Job Properties
  • Job Type
    Full-time Position
  • Category
    Finance & Accounting
  • Languages
    English
  • Experience Required
    Entry
  • Degree Required
    Bachelor
    • Province
      Hoofddorp
    • Date Posted
      September 09,2021
    • JSS
    • VISA
    • MOCKINTERVIEW
    • IMG_6430
    • Career Consultation
    • COVERLETTER CHECK
    • CV CHECK

    MES Configuration - Remote-Based

    About USDM

    USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what sets us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.

    As part of the USDM team, you have the opportunity to work with cutting edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, DocuSign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM’s clients. Are you ready to make an impact and drive real digital transformation in life sciences?

    Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.

    Nature and Scope of Job

    MES Configuration Engineer will support site Manufacturing systems (Werum 3.1.8) and will maintain a compliant, effective, and efficient operation that meets or exceeds site goals and objectives. Will work collaboratively at all levels of the organization and work well with cross-functional teams.

    Primary Responsibilities

    • Configuration of site master data.
    • Printer, Terminal, Scanner, and Scale setup.
    • Provide system troubleshooting and support.
    • User account setup.
    • Provide CRC (Configuration Release Certificate) support – documentation of master data configurations.
    • Provide CMC (Configuration Migration Certificate) support – moving recipes from between environments.
    • Coordinate the user acceptance testing of MES with peers and internal customers to ensure business requirements are achieved.
    • Provide direct internal customer support to manufacturing, site planning, inventory control, quality assurance, quality control, global master data management, and IT.
    • Troubleshoot routine and complex problems to support internal customers.
    • Assist in designing, testing, and maintaining the electronic batch record (EBR) MES Recipes and related Enterprise Resource Planning (ERP) system master data, including, but not limited to, items, specifications, lookups, list of values, recipes, routings, and formulas.
    • Translate business requirements into a robust data design and configuration which is compliant, efficient, and effective.
    • Coordinate, execute, and support User Acceptance Testing of ERP changes and MES Recipe releases with peers and internal customers to ensure business requirements are achieved.
    • Maintain the recipe release process to meet manufacturing requirements and to maintain compliant, efficient, and reliable electronic batch records and supporting data.
    • Develop and execute change controls and master data change requests for master data and MES Recipe configuration changes.

    Qualifications

    • 5+ years’ experience in applying information systems solutions to business problems.
    • 5 + years of experience with some experience with Life Science OR Pharmaceutical domain.
    • Experience gathering, documenting, communicating and managing requirements through project lifecycle
    • At least 3 years of direct experience with regulated systems (Werum) and documentation.
    • Ability to work expeditiously in an ambiguous and aggressive schedule.
    • Ability to translate requirements from business processes.
    • Solid knowledge of the application development process.
    • Strong communication skills (verbal/written/listening).
    • Sense of urgency with strong follow-up skills.
    • Detailed oriented and able to work within a team setting.

    Education & Certifications

    • Undergraduate degree, Master's degree preferred or relevant work experience in systems or business
    • 5+ years’ experience in applying information systems solutions to business problems.
    • 5 + years of experience with some experience with Life Science OR Pharmaceutical domain.

    Working Conditions

    The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job and are not meant to be all inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job.

    Unless reasonable accommodations can be made, while performing this job the staff member shall:

    • Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment.
    • Operate other office productivity machinery, such as a calculator, scanner, or printer.
    • Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations.
    • Travel to client site for onsite work as needed.

    Equal Opportunity Statement

    USDM Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

    Disclaimer

    This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

     
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