Who are we?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud -based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.
PSC Biotech is hiring a Clinical Biotechnician Specialist on behalf of one of our clients in Cork.Reporting to the relevant Manufacturing Manager, the primaryrole of the Biotechnician is to perform day to day activities within CellCulture, Purification and Process Services within the Manufacturing Group. Theywill be responsible for ensuring the manufacturing team has a successful sitestart up, process validation and product launch activities.
Main areas of responsibility:
• Performing, monitoring and troubleshooting of the cell culture, purificationor support operations within Manufacturing.
• Monitoring and reporting of process performance using statistical processcontrol.
• Support of Commissioning and Qualification activities.
• Preparation, updating and execution of Batch Records, SOPs and other GMPdocumentation.
• Provide process and equipment related training as required within theManufacturing 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 theManufacturing 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, environmentaland regulatory compliance.
• Completion of assigned tasks to support manufacture of qualitybiopharmaceuticals in accordance with cGMP and EHS requirements.
• Use Right First Time (six -sigma) and lean manufacturing practices leading tooperational excellence.
• Working flexible shift patterns to meet business needs and Manufacturingschedule
Requirements
Skills
Should be proficient in the operation of all equipment used in the respectivefunctional area of responsibility.
Education
Bachelor degree in Biotechnology, Chemical or Biochemical Engineering,Biochemistry or Bio -systems Engineering or related field or equivalentexperience is preferred.
#LI -DM2