Amgen Specialist IS Architect in Dun-Laoghaire-Rathdown, Ireland

Role Purpose

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.

Key Duties

  • 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.

Preferred Qualification

  • 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