Manufacturing Process Specialist Job Description
This position is responsible for supporting the Bioprocess Supply operations team at Janssen Sciences in Ringaskiddy, Cork. The ideal candidate will have a strong background in manufacturing and experience working in a GMP regulated environment.
Key Responsibilities:
* Liaise with planning groups to optimize shop floor scheduling activities, focusing on buffer scheduling.
* Represent Operations on cross-functional project implementation teams.
* Monitor and troubleshoot manufacturing processes and equipment issues, with a focus on process optimization.
* Use statistical process control to monitor and report process performance.
* Troubleshoot DCS (Delta V) and PLC control systems.
* Investigate and resolve issues raised within the Manufacturing Department.
* Participate in or lead Cross-Functional teams as required.
* Support Commissioning and Qualification activities.
* Prepare and update Batch Records, Procedures, and Work Instructions.
* Provide process and equipment related training within the Manufacturing Department.
Requirements:
* A relevant third-level qualification in Microbiology, Biochemistry, Pharmacy, Biotechnology, Science, or Engineering.
* Project/New equipment installation experience.
* Process engineering experience.
* Commissioning and qualification experience.
* Postgraduate Qualification.
* Experience with Microsoft Word, Excel, and Outlook.
* Experience with DCS (Delta V), SCADA, and PLC systems.
* Experience with SAP, LIM's, and/or other business systems.
* 6-Sigma/Kepner-Tregoe or similar problem-solving/decision-making methodology training.
The successful candidate will be able to work effectively in a team environment and provide excellent communication skills. This role requires a high level of technical knowledge and ability to analyze complex problems.