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Job Description
You will report to the Manager of Manufacturing for MES and will be responsible for development, configuration and testing of Master Batch Records (MBRs) from initial to final design. The successful candidate will have at least three to four years of experience in a pharmaceutical or biotech industry and will have demonstrated competency in leading teams to deliver complex MBR designs in time with project timelines.
Responsibilities
* Responsible for the development, configuration and testing of Master Batch Records (MBRs) from initial to final design within Form/Fill & Packaging functional areas, supporting existing commercial products and introduction of New Products to the site
* Responsible for leading MBR development design reviews including liaising with Operations, Process Development and Quality functions
* Responsible for drafting, executing and reviewing Application Lifecycle Management test scripts and test sets for testing MBR design
* Responsible for the support and ongoing development of the MES system in development of MBRs and improving the MES business process
* Responsible for training of Electronic Batch Record (EBR) end-users (Supervisors, Operators, Technical/QA/Support staff)
* Responsible for the development, review and update of MES Standard Operating Procedures
* Responsible for the preparation and management of MBR change requests and associated change request forms (and other documentation) in a timely manner by liaising with customers, System Owner etc.
* Accountable for adherence to established timelines and metrics for the change control and CAPA process
* Responsible for any applicable equipment integration design, configuration and testing to allow MBR interaction with shop floor equipment - OSI PI, Recipe Managers - Siemens, Rockwell, Kepware OPC Server
* Responsible for resolving interface errors and stock discrepancies between ERP/MES as required
* Liaison with MES core-team to troubleshoot and develop new ways of working
* Responsible for providing technical support where required and as directed by Operations leadership
* Other Responsibilities as deemed necessary by Executive Director Patient Supply or Manufacturing Senior Managers.
Requirements
* Bachelor's degree in Engineering or Science
* Broad technical experience in MES systems
* Experience of working in Syringe/Vial manufacturing operations or have a demonstrated capacity to learn quickly and adapt to new technology
* The ability to adapt quickly to the demands of Syringe/Vial filling
* Knowledge of regulation requirements (GMP & EH&S).
Benefits
* Competitive and attractive employee compensation package
* Pension contributions
* Sick pay
* Health insurance
* Paid public holidays.
Location: Hybrid - Dublin, Ireland
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