Mes / EBR Specialist

Pe Global

Dublin South

MBR Designer– 18 month contract. Role purpose: Responsible for the delivery of new and updated Master Batch Records for use in production. Primary Responsibilities: Accountabilities and Decisions Rights. (specific tasks and outcomes that are expected. Duties. • Responsible for the development, configuration and testing of Master Batch Records (MBRs) from initial to final design. • 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 Dun Laoghaire 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 production support to assist in fast Manufacturing Execution System (MES) issue resolution, including presence in the production suite and also during non-standard shifts. • Responsible for liaising with production managers, operators and other relevant personnel as part of the review and update of MBRs and during production as required. • 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. Technical Background: • Bachelor degree in Science, Engineering, IT or the equivalent combination of experience and education. • Typically 3-5 years of MES related experience in highly regulated GMP environments. Knowledge: • Working knowledge of solid dosage manufacturing and packaging; parenterals in pharmaceutical/biotech industries or aseptic processing. • Knowledge of regulation requirements (including cGMP, 21CFR Part11. • Knowledge of audit handling process. • Knowledge of Quality Systems (e.g. CCMS, EDMQ, NC/CAPA. • Knowledge of validation processes and understanding of validation protocol generation requirements. • Knowledge of computer systems applicable to responsibilities (e.g. MES, ERP, QMTS, EDMQ. • Practical knowledge in continuous improvement tools and methodologies. Skills: • MES experience with focus on workflow, S95 & S88 standards & integration from the control layer to ERP via MES. • Strong attention to details, including the ability to proofread documents and to accurately translate customers’ requirements into meaningful end-user instructions consistently. • Ability to interpret requirements and apply GMP and regulatory Knowledge as related to documentation. • Project Management. • Excellent organisational and communication (verbal and written) skills at all levels of the organisation. • Strong Technical writing for investigations, procedures and change controls. Please send in your Cv for the attention of Robert Carroll or contact 021 4520311 for more information. This job originally appeared on RecruitIreland.com.

2191 days ago