PAS-X Engineer

2 weeks ago

Dublin, Ireland Oxford Global Resources Full time

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. Werum PAS-X proficiency is required for this role. ResponsibilitiesResponsible 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 siteResponsible for leading MBR development design reviews including liaising with Operations, Process Development and Quality functionsResponsible for drafting, executing and reviewing Application Lifecycle Management test scripts and test sets for testing MBR designResponsible for the support and ongoing development of the MES system in development of MBRs and improving the MES business processResponsible 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 ProceduresResponsible 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 processResponsible 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 ServerResponsible for resolving interface errors and stock discrepancies between ERP/MES as requiredLiaison with MES core-team to troubleshoot and develop new ways of workingResponsible for providing technical support where required and as directed by Operations leadershipOther Responsibilities as deemed necessary by Executive Director Patient Supply or Manufacturing Senior Managers.RequirementsBachelor's degree in Engineering or ScienceBroad technical experience in MES systemsExperience of working in Syringe/Vial manufacturing operations or have a demonstrated capacity to learn quickly and adapt to new technologyThe ability to adapt quickly to the demands of Syringe/Vial fillingKnowledge of regulation requirements (GMP & EH&S). BenefitsCompetitive and attractive employee compensation packagePension contributionsHealth insurancePaid public holidays. Location: Hybrid - Dublin, Ireland

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