Job Title: Manufacturing Process Specialist
Reporting to Operations Manager, this position is responsible for representing operations on capital project teams and supporting first line troubleshooting of the day-to-day activities within Operations.
* Represent Operations on cross functional project implementation teams.
* Monitoring and troubleshooting of the manufacturing process and equipment issues and process optimization
* Monitoring and reporting of process performance using statistical process control
* Troubleshooting of DCS (e.g Delta V) and PLC control systems
* Investigating and resolving issues raised within the Manufacturing Department
* Participate in/ Lead Cross Functional teams when required.
* Support of Commissioning and Qualification activities
* Preparation and updating of Batch Records, Procedures and Work Instructions
* Provide process and equipment related training as required within the Manufacturing Department
* Completion of assigned tasks to support manufacture of quality biomedicines in accordance with cGMP and EHS requirements.
The ideal candidate will have a relevant third level qualification in either Microbiology, Biochemistry, Pharmacy, Biotechnology, Science or Engineering. Desirable qualifications include manufacturing experience within a GMP regulated environment, experience of the cell culture or purification processes, project / new equipment installation experience, process engineering experience, commissioning and qualification experience, postgraduate qualification, experience of Microsoft Word, Excel and Outlook, experience of DCS (e.g Delta V), SCADA and PLC systems, experience of SAP, LIM's and/or other business systems, 6-Sigma/Kepner-Tregoe or similar problem solving/decision making methodology training.
MUST ALREADY BE ELIGIBLE TO WORK ON CONTRACT IN THE REPUBLIC OF IRELAND- i.e have a valid work permit with 12 months permission + on it