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.

Operations Bioprocess Special

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

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. Commit to and demonstrate safe behaviour in every activity

•      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

•      Compliance with Operations and general site procedures at all times.

•      Actively participate in PC&D process

•      Completion of all documentation in compliance with site procedures and GDP

•      Execution of activities as necessary to meet operational and business needs

•      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

•      Prioritize and schedule activities to support business needs and to meet requirements of

Master Production Schedule

•      Lead and Support investigation and resolution of problems on plant

•      Participate in and lead Cross-Functional teams as necessary

•      Participate in Emergency Response/Fire/First Aid teams as necessary

•      Generate and assist with generation, review and revision of Operations documentation as

necessary

·      Ensure that personal training requirements are completed in compliance with site procedures. Training and support for new recruits to the Operations group         

·      Support ongoing studies by Validation, OTS and other support functions

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 0214665408 and email [email protected]