Amgen Specialist IS Architect in Dun-Laoghaire-Rathdown, Ireland
Responsible for the delivery of new and updated integration functionalities for Manufacturing Information Systems for use in production. Responsible for oversight on alignment of Manufacturing Information Systems with Global Operating Specifications.
Responsible for the development, configuration and testing for integration components of Master Batch Records (MBRs) from initial to final design.
Responsible for leading integration development design reviews including liaising with Automation, Operations, Process Development, Validation and Quality functions
Responsible for any applicable equipment integration design, configuration and testing to allow MBR interaction with shop floor equipment and lab equipment for in-process testing
Responsible for liaising with Plant Support, System Owner and Operations teams regarding documentation changes in an effective and timely manner
Responsible for support and updates to Recipe Control system - an in-house online recipe management system at Amgen Dun Laoghaire.
Responsible for the MBR design oversight, support and ongoing development of the Amgen Dun Laoghaire MES system
Responsible for training of Electronic Batch Record (EBR) designers and end-users on MES integration activities and development of job aids
Responsible for support and to assist in fast Manufacturing Execution System (MES) issue resolution where required and as directed by Operations leadership
Responsible for the development, review and update MES Standard Operating Procedures and Design Specifications Continuous improvement & Projects
Support continuous area improvement, by proactively identifying and supporting implementation of improvement opportunities for MES integration removing paper from the execution and review process to reduce cycle times
Support implementation of process changes Safety
Responsible to perform all activities in compliance with Amgen safety standards and site safety procedures.
Working knowledge of drug product manufacturing and packaging in pharmaceutical/biotech industries or aseptic processing
Knowledge of regulation requirements (including cGMP, 21CFR Part11)
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, SCADA, PLC, Historian)
Practical knowledge in continuous improvement tools and methodologies Skills:
MES experience with focus on workflow, S95 & S88 standards and integration from the control layer to MES in pharma & bio-pharma industries
Strong capabilities in S95 level 2 and level 3 systems and their integration.
Strong working knowledge of OLE for Process Control,
Experience of Supervisory Control and Data Acquisition (SCADA), Process Control Systems (PCS), Recipe Managers - Siemens, Rockwell, Kepware OPC Server, OSI Pi, RT Reports, OSI PI Asset Framework, Laboratory benchtop equipment, Learning Management Systems
Strong exposure to MES technologies, including automated data collection, historian applications (OSI PI), visualization, quality and efficiency in manufacturing
MES experience in implementing stable and scalable solutions for
Continuous Data Retrieval from Level 2 and Level 3 systems
Creation / Loading of Level 2 Recipes
Retrieval of Alarms and Events (Batch Context Information) into MES for Annotation, Review and Trending
Strong PL/SQL programming experience in software development with Microsoft Visual Studio / Development tools; knowledge of web services, ASP and .net technologies.
Strong SQL experience with exposure to both Oracle & SQL Server databases along with Crystal Reports
Strong attention to details, including the ability to proof read documents and to accurately translate customers' requirements into meaningful end-user instructions consistently
Excellent organizational and communication (verbal and written) skills at all levels of the organization