Clinical Biotechnician

PSC Biotech is hiring a Clinical Biotechnician Specialist on behalf of one of its clients in Cork. The role involves performing day-to-day activities within Cell Culture, Purification and Process Services within the Manufacturing Group.

Requirements

• Performing, monitoring and troubleshooting of cell culture, purification or support operations within Manufacturing.
• Monitoring and reporting of process performance using statistical process control.
• Support of Commissioning and Qualification activities.
• Preparation, updating and execution of Batch Records, SOPs and other GMP documentation.
• Provide process and equipment related training as required within the Manufacturing Department.
• Troubleshooting of process specific equipment.
• Troubleshooting of DCS (e.g. Delta V) and PLC control systems.
• Authoring, investigating and resolving quality deviations raised within the Manufacturing Department.
• Participate in/ Lead Cross Functional team initiatives when required.
• Participate in the execution of validation protocols.
• Demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance.
• Completion of assigned tasks to support manufacture of quality biopharmaceuticals in accordance with cGMP and EHS requirements.
• Use Right First Time (six-sigma) and lean manufacturing practices leading to operational excellence.
• Working flexible shift patterns to meet business needs and Manufacturing schedule