Manufacturing Process Specialist
Reporting to the Operations Manager, this position is responsible for BU4 Bioprocess supply operations, supporting Capital Project Teams and troubleshooting day-to-day activities within Operations.
Key Responsibilities:
1. Liaise with the planning group to optimize BU4 shop floor scheduling activities, focusing on buffer scheduling.
2. Represent Operations on cross-functional project implementation teams.
3. Monitor and troubleshoot manufacturing process and equipment issues, with a focus on process optimization.
4. Track and report process performance using statistical process control.
5. Troubleshoot DCS (e.g., Delta V) and PLC control systems.
6. Investigate and resolve Manufacturing Department issues.
7. Participate in/lead Cross-Functional teams as required.
8. Support Commissioning and Qualification activities.
9. Prepare and update Batch Records, Procedures, and Work Instructions.
10. Provide process and equipment-related training within the Manufacturing Department.
11. Complete assigned tasks to support manufacture of quality biomedicines, adhering to cGMP and EHS requirements.
Requirements:
1. A relevant third-level qualification in Microbiology, Biochemistry, Pharmacy, Biotechnology, Science, or Engineering.
2. Manufacturing experience in a GMP-regulated environment.
3. Experience in cell culture, purification, or biologics manufacturing support processes.
4. Project/new equipment installation experience.
5. Process engineering experience.
6. Commissioning and qualification experience.
7. Postgraduate qualification.
8. Microsoft Word, Excel, and Outlook experience.
9. DCS (e.g., Delta V), SCADA, and PLC system experience.
10. SAP, LIM's, and/or other business system experience.
11. 6-Sigma/Kepner-Tregoe problem-solving/decision-making methodology training.
Eligibility:
Must be eligible to work on contract in the Republic of Ireland, with a valid work permit and 12 months' permission.