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  • 15h Left: Manufacturing Process Specialist - Cork - CPL

    CPL
    CPL Cork

    3 weeks ago

    CPL background
    Description

    Manufacturing Process Specialist

    Kenny-Whelan, a specialist division of the CPL group, is recruiting two Manufacturing Process Specialists to work on the Material Supply Optimization Team at Janssen Sciences in Ringaskiddy.

    Key Responsibilities:

    • Evaluate dual source alternatives for single-use materials such as filters, bags, assemblies, and tubing to determine suitability for introduction to Janssen Cork.
    • Generate technical drawings for alternative material design proposals by second-source suppliers.
    • Evaluate current material usage and suitability testing of proposed material alternatives.
    • Present to Change Control Board and raise Change Controls for materials determined as suitable alternative for current materials.
    • Update and compile material documentation and data to support review and implementation process.
    • Attend daily team and departmental meetings.
    • Communicate with various departments for material scoping and implementation of alternative material.
    • Liaise with vendors and the wider members of the Cork Bio site to obtain relevant information for the completion of change controls.
    • Investigate and resolve issues associated with change controls.
    • Liaise with procurement, Material Sciences, and Technical Operations to ensure all technical requirements for new components have been met.
    • Update recipes with Filter Integrity Requirements for new filters as required.

    Leadership Responsibilities/Individual Contribution:

    • Report to Manufacturing Readiness Manager.
    • Represent the Cork BOOST Team on cross-functional project teams.
    • Familiarize yourself with daily activities in Manufacturing.
    • Facilitate an environment of continuous improvement.
    • Facilitate an environment of open communication.
    • Lead investigations in the work area as necessary.
    • Lead Cross-Functional teams as necessary to support site goals.
    • Support training of other Manufacturing colleagues.

    Qualifications and Experience:

    • Essential qualifications include a relevant third-level qualification in Microbiology, Biochemistry, Pharmacy, Biotechnology, Science, or Engineering.
    • Desirable qualifications include manufacturing experience within a GMP regulated environment, project/new equipment installation experience, process engineering experience, commissioning and qualification experience, postgraduate qualification, experience with Microsoft Word, Excel, and Outlook, experience with SAP, electronic documentation system, and/or other business systems, 6-Sigma/Kepner-Tregoe or similar problem-solving/decision-making methodology training.

    Organisational Interfaces:

    Interface at Team Leader, Manager, and Director level with all site departments, Operations, and Maintenance. Contact with Engineering, Quality, Logistics, OTS, Validation, and Training departments. Contact with other Janssen Biologics sites. Be conscious of internal customers to the Manufacturing department and be cognizant of their requirements.

    Job Requirements:

    • A valid work permit with 12 months permission.
    • Eligibility to work on contract in the Republic of Ireland.

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