Kenny-Whelan (a specialist division of the CPL group) are recruiting 2 x Operations Bioprocess Specialists to work on contract at Janssen Sciences in Ringaskiddy Level 8+ Degree essential Not a production operator/Light Industrial role.
MUST ALREADY BE ELIGIBLE TO WORK ON CONTRACT IN THE REPUBLIC OF IRELAND- i.e have a valid work permit with 12 months permission + on it POSITION SUMMARY: Reporting to the relevant Operations Team Leader, this position is responsible for first line trouble-shooting of the day to day activities within either Cell Culture, Purification or Equipment Prep.
These activities include but are not confined to: General Activities Monitoring and troubleshooting of the Operations processes 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 Process Specific Equipment Troubleshooting of DCS (e.g Delta V) and PLC control systems Investigating and resolving Deviations raised within the Operations 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 Operations Department Completion of assigned tasks to support manufacture of quality biomedicines in Operations Bioprocess Specialist accordance with cGMP and EHS requirements Working assigned shift patterns to meet business needs and Operations schedule Cell Culture Activities Troubleshooting of Media Preparation, filtration and storage.
Troubleshooting of Preculture and Cell Culture Purification Activities Monitoring and Troubleshooting of Buffer Preparation Monitoring and Troubleshooting Column Packing activities Monitoring and Troubleshooting of DPC and Purification of product Monitoring and Troubleshooting of Final filtration, filling and finishing of purified product Management and control of Purification process database Equipment Prep Activities Troubleshooting and optimization of washers and autoclaves to clean and sterilize equipment Troubleshooting and optimization of COP and SOP booths and CIP skids Troubleshooting and optimization of decontamination autoclaves Develop and implement systems and procedures in the equipment preparation and weigh dispense areas Monitoring and responding to changes in business, operational, and quality metrics Optimize throughput in equipment preparation and weigh dispense areas QUALIFICATIONS AND EXPERIENCE A relevant third level qualification in either Microbiology, Biochemistry, Pharmacy, DESIRABLE Biotechnology, Science or Engineering Postgraduate Qualification.
Operations experience within a GMP regulated environment.
Experience of Buffer or Media preparation or Equipment preparation in an Operations environment All applications will be treated with the strictest of confidence .
Contact Jenn Dinan on and email MUST ALREADY BE ELIGIBLE TO WORK ON CONTRACT IN THE REPUBLIC OF IRELAND- i.e have a valid work permit with 12 months permission + on it Skills: Cell culture Prcess Optimization Media Preparation Buffer preparation Purification Benefits: Paid Holidays Parking Staff Discounts