Operations Bioprocess Specialist
We are recruiting 2 x Operations Bioprocess Specialists to work on contract at Janssen Sciences in Ringaskiddy.
Key Responsibilities:
* First line troubleshooting of day-to-day activities within Cell Culture, Purification or Equipment Prep.
* 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 and 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.
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.
General Scope of Responsibilities:
* Travel to other Janssen Biologics (Ireland), J&J and other external sites for business relevant activities as required.
* Lead by example and strive to perform to high standards at all times.
* Responsible and accountable for assuring the safe accomplishment of job activities, following good environmental practices and procedures.
* Carry out routine and non-routine tasks delegated by the Team Leader according to appropriate procedures, values and standards.
* Carry out all activities in compliance with corporate and cGMP/EHS regulatory requirements.
Qualifications and Experience:
A relevant third level qualification in either Microbiology, Biochemistry, Pharmacy, Biotechnology, Science or Engineering is essential.
Desirable qualifications include a postgraduate qualification, operations experience within a GMP regulated environment, and experience of buffer or media preparation or equipment preparation in an operations environment.