Senior Manufacturing Process Specialist
Reporting to Operations Manager, this position is responsible for first line trouble-shooting of the day to day activities within Operations - These activities include but are not confined to:
·Monitoring and troubleshooting of the manufacturing process and equipment issues and process optimization
·Monitoring and reporting of process performance using statistical process control
·Generation of data and reports to support Annual Product Reviews and Regulatory submissions
·Troubleshooting of DCS (e.g Delta V) and PLC control systems
·Investigating and resolving Deviations 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
·Lead, support and participate in commissioning and qualification activities both current and future projects (and annual re-qualification activities). Also support to validation activities.
·Prioritize and schedule activities to support business needs and to meet requirements of Master Production Schedule.
·Lead and Support investigation and resolution of problems on plant.
·Participate in and lead Cross-Functional teams as necessary.
·Support ongoing studies by Validation, OTS and other support functions.
·A relevant third level qualification in either Microbiology, Biochemistry, Pharmacy, Biotechnology, Science or Engineering
·Experience of Buffer or Media preparation or Equipment preparation in a manufacturing environment.
·Experience of the cell culture or purification processes in either a manufacturing or a lab based environment.
·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.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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