Job Title: Manufacturing Process Specialist
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This role is responsible for supporting the BU4 Bioprocess Supply operations team at Janssen Sciences in Ringaskiddy, Cork. The successful candidate will work on a contract basis and report directly to the Operations Manager.
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Key Responsibilities:
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* Liaise with the planning group to optimize shop floor scheduling activities, with a focus on buffer scheduling.
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* Represent Operations on cross-functional project implementation teams.
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* Monitor and troubleshoot manufacturing process and equipment issues, as well as optimize processes.
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* Monitor and report process performance using statistical process control.
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* Troubleshoot DCS (e.g. Delta V) and PLC control systems.
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* Investigate and resolve issues raised within the Manufacturing Department.
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* Participate in/lead Cross-Functional teams when required.
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* Support Commissioning and Qualification activities.
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* Prepare and update Batch Records, Procedures, and Work Instructions.
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* Provide process and equipment-related training as required within the Manufacturing Department.
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* Complete assigned tasks to support manufacture of quality biomedicines in accordance with cGMP and EHS requirements.
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Requirements:
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* A relevant third-level qualification in Microbiology, Biochemistry, Pharmacy, Biotechnology, Science, or Engineering.
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* Manufacturing experience within a GMP regulated environment.
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* Experience of cell culture, purification, or biologics manufacturing support processes.
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* Project/New equipment installation experience.
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* Process engineering experience.
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* Commissioning and qualification experience.
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* Postgraduate Qualification.
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* Experience of Microsoft Word, Excel, and Outlook.
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* Experience of DCS (e.g. Delta V), SCADA, and PLC systems.
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* Experience of SAP, LIM's, and/or other business systems.
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* 6-Sigma/Kepner-Tregoe or similar problem-solving/decision-making methodology training.
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Eligibility: Must already be eligible to work on contract in the Republic of Ireland, with a valid work permit and 12 months' permission.
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Location: Cork – Ringaskiddy
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