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Sr. Manager MES

2 months ago

Dublin, Ireland Amgen Full time

The Senior Manager of Manufacturing at Amgen is responsible for overseeing all manufacturing operations. They manage the manufacturing team, ensure production meets quality and efficiency standards, and drive initiatives for continuous improvement.

ADL: L6 - Sr. Manager MES (Manufacturing Support)

Job Description

Overview

We are looking for a senior manager of manufacturing execution system (MES) to join Amgen Dun Laoghaire, a state-of-the-art biologics manufacturing facility. You will report to the Director of Manufacturing Support and lead our team of MES Mangers and designers in both the commercial and new product Introductions space. You will oversee the design, development, implementation, and maintenance of MES solutions for our site operations. You will also manage the budget, schedule, quality, and scope of MES projects, as well as provide technical guidance and mentorship to your team members. Additionally, you will be responsible for driving site MES optimization and MES standardization initiatives to enhance operational efficiency and quality compliance at the Dun Laoghaire site and align with the global and regional MES strategies and roadmaps.

Responsibilities

  • Manage the full lifecycle of MES projects, from planning and scoping to testing and deployment.

  • Lead and be the decision maker for the GMBR Governance Program and content of GMBRs by enforcing standards proactively.

  • Lead, coordinate and manage prioritization and timelines of GMBR creation/revisions, and continuously improve to reduce cycle time.

  • Ensure that MES solutions meet the business and regulatory requirements, specifications, and standards of Amgen and its customers.

  • Coordinate with other teams and stakeholders, such as IT, operations, quality, and vendors, to ensure smooth integration and alignment of MES with other systems and processes.

  • Monitor and troubleshoot MES performance and provide timely and effective resolutions.

  • Prepare and present project status reports, metrics, and documentation to senior management and customers.

  • Lead, coach, and motivate the MES team, and foster a culture of collaboration, innovation, and excellence.

  • Identify and implement best practices, tools, and methodologies for MES development and management.

  • Stay updated on the latest trends, technologies, and standards in the MES domain, and evaluate and recommend new solutions and improvements.

  • Lead and execute site MES optimization and MES standardization projects, and ensure alignment with global and regional MES strategies and roadmaps.

  • Support the site implementation of MES solutions, and provide training and support to end users.

  • 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 Support Director.

Qualifications

  • Bachelor's degree in engineering, computer science, or related field.

  • At least 10 years of experience in MES development, implementation, and management, preferably in a biotechnology or pharmaceutical environment.

  • Strong knowledge of MES concepts, architectures, standards, and functionalities, such as ISA-95, B2MML, OEE, traceability, and quality management.

  • Proficient in MES software platforms, such as Siemens, Rockwell, SAP, or GE.

  • Experience in integrating MES with ERP, PLC, SCADA, LIMS, and other systems.

  • Excellent project management, communication, leadership, and problem-solving skills.

  • Ability to work under pressure, manage multiple tasks and deadlines, and adapt to changing priorities and business needs.

  • Willingness to travel to other manufacturing sites as needed.