We are seeking two Operations Bioprocess Specialists to work on a contract basis at Janssen Sciences in Ringaskiddy. The ideal candidate will have a degree equivalent to Level 8, and relevant experience in a GMP regulated environment is desirable.
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.
* 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 accordance with cGMP and EHS requirements.
Requirements:
* A relevant third level qualification in either Microbiology, Biochemistry, Pharmacy, Biotechnology, Science or Engineering.
* Desirable qualifications include a postgraduate qualification and experience of Buffer or Media preparation or Equipment preparation in an Operations environment.
Contact Information: