Manufacturing Process Specialist - Purification, Contract, Cork
Reporting to the Purification Business Unit, this position is responsible for supporting manufacturing activities associated with the purification and process support of monoclonal antibodies.
* 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
Main duties and responsibilities:
* Technical Lead for purification 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
Key Skills and Competencies required:
* Excellent interpersonal skills
* Ability to operate as part of a team is critical.
* Customer focus
* Mechanical/Technical aptitude
* Excellent communication skills both written and verbal
* Attention to detail
* Good problem solving skills
* Results and performance driven
* Adaptable and flexible
For more information on this role please "Apply" or contact Eleanor Collins @ Morgan McKinley, 021 2300 300
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.