Process Engineer

Unither Pharmaceuticals, LLC

  • ROCHESTER, NY
  • 8 days ago

    Highlights

    Projects include but are not limited to: manufacturing systems, sterile filing systems, process piping, utility systems, new facility construction and upgrades, and other applications. Ensure that technical choices which may deviate from established specifications, or the implicit expectations of internal customers are documented and validated in a formal manner.

    Numbers & Facts

    LocationROCHESTER, NY

    Description

    JOB SUMMARY:

    Serves as a technical resource supporting company objectives with respect to engineering design, process, and implementation of chemical process and controls. Projects include but are not limited to: manufacturing systems, sterile filing systems, process piping, utility systems, new facility construction and upgrades, and other applications.

    ESSENTIAL DUTIES / RESPONSIBILITIES:

    Engage in technical discussions with potential suppliers

    Organize and write specifications based on the needs and requirements

    Launch calls for tenders (Request for Proposal, Request for Service)

    Ensure the solution designed respects the established specifications(s)

    Ensure that technical choices which may deviate from established specifications, or the implicit expectations of internal customers are documented and validated in a formal manner.

    Execute Projects and Tasks to the approved completion deadlines and within the defined budget

    Work in partnership with external companies

    Propose and apply solutions to mitigate and compensate for possible work delays

    Proactively alert site management to potential problems

    Ensure the successful commissioning of the project

    Monitor the installations and commissioning of equipment

    Coordinate the various suppliers and vendors and ensure their compliance to health and safety instructions

    Possess adequate technical expertise allowing problem resolution

    Respect the data in the specifications

    Communicate with Production to coordinate activities with respect to production constraints

    Assist with commissioning activities and in putting the equipment into production

    Carry out an assessment after each commissioning

    Serves in an expert role in writing the qualification protocol, execution of the tests and approval of any resulting report.

    Participate in operator training (training)

    Work with internal customers to define the training requirement and provide technical content

    Organize training in collaboration with suppliers

    Study the technical needs associated with new site investments

    Participate in different project groups

    Collect and analyze needs from internal stakeholders

    Define technical solutions and implementations

    Respect the technical, regulatory and quality requirements issued by Management and Quality Assurance.

    Take into account the necessary parameters (water production, energy, etc.)

    Respect flows, workshop ergonomics and safety constraints

    Ensure the documentation of completed projects is updated

    Collect technical drawings from vendors for review and ensure they reflect the realized design

    Create technical drawings of the factory and update according to approved documentation practices

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