Mes Engineer

Independent Solutions

Dublin

Description : MBR Designer. 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 Amgen 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 Amgen 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. Business Execution and Compliance. • Responsible for owning and tracking Change controls as required and in a timely manner. • Responsible for liaising with Quality Assurance to ensure that GMP standards are maintained in line with current SOPs, batch documentation and processes. Non-Conformance and CAPA. • Responsible for owning and tracking Corrective and Preventative Actions (CAPAs) as required. • Responsible for Class 1 NCs as required. • Support other investigations, Non-Conformance and CAPA Review Boards where required. • Responsible for the implementation of Change Controls related to the Manufacturing facility. • Responsible for contributing to and assisting with Corporate, FDA, IMB Auditors and other regulatory bodies during company audits. • Support any internal & external regulatory agencies activities during inspections. Staff Training and Qualification. • Responsible for personal GMP training compliance. • Support technical training assignments for staff in Patient Supply. Continuous improvement & Projects. • Support continuous area improvement, by proactively identifying and supporting implementation of improvement opportunities. • Support implementation of process changes. Safety. • Responsible to perform all activities in compliance with Amgen safety standards and site safety procedures. Business/Administrative. • Responsible for development of personal annual reviews, goal setting and Individual Development Plans via the Maximizing Amgen Performance (MAP) process. • Support the MAP process by completing peer to peer feedback. • May perform some limited NC Owner duties as required. Primary knowledge, skills, competencies and relevant experience: 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. • Reliable, pro-active, motivated and enthusiastic individual. • Ability to help others understand and implement complex instructions. • Ability to work guided by objectives of the department or assignments. • Refers to established policies and precedents as needed. • May set project timeframes and priorities based on project objectives and ongoing assignments. • Recognizes and escalates problems. Competency : • Contributes to department/unit by ensuring quality of tasks/services provided by self. • Contributes to the completion of milestones associated with specific projects or activities within own department or workgroup. • Applies knowledge and understanding of internal customer needs. • Establishes working relationships with others outside area. This job originally appeared on RecruitIreland.com.

2192 days ago