Manufacturing Process Specialist

KENNY-WHELAN AND ASSOCIATES

CORK

Position Title: Manufacturing Process Specialist. Department: Operations. Report to: Purification Business Unit Manager. Location: Ringaskiddy, Cork. Job Purpose. Reporting to the Purification Business Unit, this position is responsible for supporting manufacturing activities associated with the purification and process support of monoclonal antibodies. Responsibilities: Technical Lead for purifcation process and providing process and equipment related training as required. Supporting technology transfer of new & existing processes to the site. 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. Completion of assigned tasks to support manufacture of quality biomedicines in accordance with cGMP and EHS requirements. Working assigned shift patterns to meet business needs and Operations schedule. Preparation and updating SOPs & WIs. Lead by example and strive to perform to high standards at all times. Experience & Qualifications: To be part of this high performing team you will have great attention to detail and have. • A relevant third level qualification in either Microbiology, Biochemistry, Pharmacy, Biotechnology, Science or Engineering. • Understanding of the requirements of cGMP and familiarity with other relevant regulatory requirements. For more information or to submit your CV please contact skelleher@kenny-whelan.ie.

1595 days ago