A Manufacturing Process Specialist is required on an initial 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 day-to-day activities within Operations.
Role Responsibilities
* Represent Operations on cross-functional project implementation teams.
* Monitor and troubleshoot the manufacturing process and equipment issues, as well as process optimization.
* Monitor and report process performance using statistical process control.
* Troubleshoot DCS (e.g., Delta V) and PLC control systems.
* Investigate and resolve issues raised within the Manufacturing Department.
* Participate in/lead Cross Functional teams when required.
* Support Commissioning and Qualification activities.
* Prepare and update Batch Records, Procedures, and Work Instructions.
* Provide process and equipment-related training as required within the Manufacturing Department.
* Complete assigned tasks to support manufacture of quality biomedicines in accordance with cGMP and EHS requirements.
Requirements
* A relevant third-level qualification in either Microbiology, Biochemistry, Pharmacy, Biotechnology, Science, or Engineering.
Desirable Skills
* 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, LIMS, and/or other business systems.
* 6-Sigma/Kepner-Tregoe or similar problem-solving/decision-making methodology training.