Job Description
A Manufacturing Process Specialist is required on an initial 12-Month basis by CareerWise Recruitment for our Cork-based multinational pharmaceutical Company. 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.
THE ROLE
1. Represent Operations on cross functional project implementation teams.
2. Monitoring and troubleshooting of the manufacturing process and equipment issues and process optimization
3. Monitoring and reporting of process performance using statistical process control
4. Troubleshooting of DCS (e.g. Delta V) and PLC control systems
5. Investigating and resolving issues raised within the Manufacturing Department
6. Participate in/ Lead Cross Functional teams when required.
7. Support of Commissioning and Qualification activities
8. Preparation and updating of Batch Records, Procedures and Work Instructions
9. Provide process and equipment related training as required within the Manufacturing Department
10. Completion of assigned tasks to support manufacture of quality biomedicines in accordance with cGMP and EHS requirements.
REQUIREMENTS
11. A relevant third level qualification in either Microbiology, Biochemistry, Pharmacy, Biotechnology, Science or Engineering
DESIRABLE:
12. Manufacturing experience within a GMP regulated environment.
13. Experience of the cell culture or purification processes
14. Project / New equipment installation experience
15. Process engineering experience
16. Commissioning and qualification experience
17. Postgraduate Qualification.
18. Experience of Microsoft Word, Excel and Outlook.
19. Experience of DCS (e.g. Delta V), SCADA and PLC systems
20. Experience of SAP, LIM’s and/or other business systems.
21. 6-Sigma/Kepner-Tregoe or similar problem solving/decision making methodology training.