Maja Smilevska

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    Syncade Engineer

    Ref #: Syncade Engineer
    Maja Smilevska 16/05/2023
    Location: United States, New Hampshire, Hybrid Not Disclosed United States, New Hampshire, Hybrid
    Salary: $125K £
    Type: Permanent
    Sector: Pharma | Biotec
    Seniority: Mid/Senior Level
    Specialisms: MES | Syncade | Manufacturing | Recipe Author
    Date: 16/05/2023
    Syncade Engineer

    Our client are a global leader in life sciences operating, and are seeking 3 experienced MES Engineers who will be responsible for driving and leading activities such as requirements gathering, recipe authoring, testing and implementation.

    This position is expected to operate with a high degree of autonomy with only general supervision.

    Key Responsibilities:

    • Manufacturing Support

    • Develop technical knowledge on manufacturing equipment and process automation systems.

    • Manage resolution of equipment breakdowns and quality issues in the suites.

    • Provide SME support to Manufacturing and other departments for the design and operation of process automation equipment.

    • Conduct troubleshooting and technical analyses on manufacturing equipment and process automation systems including PI data analyses, CIP/SIP circuit review, flow path analyses, code review/troubleshooting, etc.

    • Assist with tech transfer of new processes into the facility.
    • Complete change request lot assessments to support lot release.

    • Participates in IPT/JPT meetings and customer ad hoc meetings as MES SME.

    • Represents group at MES DMS meetings.

    • Participates in audits and inspections as MES SME. Projects

    • Planning and execution of plant projects involving automation changes and process improvements including lump sum capital projects.

    • Execute test scripts (design, execution, simulation, wet testing).

    • Own change requests and complete change request tasks to support project completion.

    • Perform change request assessments.

    • Deviations / RCAs

    • Assist the Quality department with deviation investigations.

    • Performs MES review/approval of deviations.

    • Participate in RCAs as MES representative.

    • Owns and executes completion of CAPA actions.

    • Participates in quality risk assessments.

    Key Requirements:

    • Bachelor’s degree in science, technology, engineering or mathematics.

    • Syncade Recipe Authoring experience strongly preferred.

    • 3-7 years experience working in automation in a Pharm/Biotech environment.

    • Advanced Recipe Author (in Syncade).

    • Ability to secure relevant information and identify key issues and relationships from a base of information.

    • Evaluate engineering problems and be able to devise cause and effect relationships and propose solutions.

    • Adapt to changing conditions.

    To schedule with me, please use the booking link here https://calendly.com/maja-smilevska

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