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.
POSITION SUMMARY:
Reporting to the relevant Operations Team Leader, this position is responsible for first line troubleshooting of the day-to-day activities within either Cell Culture, Purification or Equipment Prep. These activities include but are not confined to:
General Activities
1. Monitoring and troubleshooting of the Operations processes and process optimization.
2. Monitoring and reporting of process performance using statistical process control.
3. Generation of data and reports to support Annual Product Reviews and Regulatory submissions.
4. Troubleshooting of Process Specific Equipment.
5. Troubleshooting of DCS (e.g., Delta V) and PLC control systems.
6. Investigating and resolving Deviations raised within the Operations Department.
7. Participate in/Lead Cross Functional teams when required.
8. Support of Commissioning and Qualification activities.
9. Preparation and updating of Batch Records, Procedures and Work Instructions.
10. Provide process and equipment related training as required within the Operations Department.
11. Completion of assigned tasks to support manufacture of quality biomedicines in accordance with cGMP and EHS requirements.
12. Working assigned shift patterns to meet business needs and Operations schedule.
Cell Culture Activities
1. Troubleshooting of Media Preparation, filtration and storage.
2. Troubleshooting of Preculture and Cell Culture.
Purification Activities
1. Monitoring and Troubleshooting of Buffer Preparation.
2. Monitoring and Troubleshooting Column Packing activities.
3. Monitoring and Troubleshooting of DPC and Purification of product.
4. Monitoring and Troubleshooting of Final filtration, filling and finishing of purified product.
5. Management and control of Purification process database.
Equipment Prep Activities
1. Troubleshooting and optimization of washers and autoclaves to clean and sterilize equipment.
2. Troubleshooting and optimization of COP and SOP booths and CIP skids.
3. Troubleshooting and optimization of decontamination autoclaves.
4. Develop and implement systems and procedures in the equipment preparation and weigh dispense areas.
5. Monitoring and responding to changes in business, operational, and quality metrics.
6. Optimize throughput in equipment preparation and weigh dispense areas.
GENERAL SCOPE OF RESPONSIBILITIES:
1. Travel to other Janssen Biologics (Ireland), J&J and other external sites for business relevant activities as required.
2. Lead by example and strive to perform to high standards at all times.
3. Responsible and accountable for assuring the safe accomplishment of job activities, following good environmental practices and procedures. Commit to and demonstrate safe behaviour in every activity.
4. Carry out routine and non-routine tasks delegated by the Team Leader according to appropriate procedures, values and standards.
5. Carry out all activities in compliance with corporate and cGMP/EHS regulatory requirements.
6. Compliance with Operations and general site procedures at all times.
7. Actively participate in PC&D process.
8. Completion of all documentation in compliance with site procedures and GDP.
9. Execution of activities as necessary to meet operational and business needs.
10. Lead, support and participate in commissioning and qualification activities both current and future projects (and annual re-qualification activities). Also provide support to validation activities.
11. Prioritize and schedule activities to support business needs and to meet requirements of Master Production Schedule.
12. Lead and Support investigation and resolution of problems on plant.
13. Participate in and lead Cross-Functional teams as necessary.
14. Participate in Emergency Response/Fire/First Aid teams as necessary.
15. Generate and assist with generation, review and revision of Operations documentation as necessary.
16. Ensure that personal training requirements are completed in compliance with site procedures. Training and support for new recruits to the Operations group.
17. Support ongoing studies by Validation, OTS and other support functions.
QUALIFICATIONS AND EXPERIENCE:
A relevant third level qualification in either Microbiology, Biochemistry, Pharmacy, Biotechnology, Science or Engineering.
DESIRABLE:
1. Postgraduate Qualification.
2. Operations experience within a GMP regulated environment.
3. 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 0214665408 and email jdinan@kenny-whelan.ie
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