Sr Associate Digital Manufacturing

Join Amgen's Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared mission to serve patients living with serious illnesses drives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions.

As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your

Lets do this. Lets change the world. In this role you will lead various smart manufacturing technology and computerized systems initiatives within manufacturing to support the end user on the shop floor (e.g. AR/VR Technology, MES, ERP, SCADA, Systech, Serialization). You will manage critical processes, provide technical leadership, and be accountable for designing, implementation, and validation of key business systems and digital technologies.

You will support the development of master batch records, technical reports, and other Good Manufacturing Practices (GMP) documents that supports smart manufacturing technology and the production process. This role is essential for Amgen Ohios success and key in supporting operations towards the digital future of tomorrow.

• Provides technical support, project management, and problem solving assistance of various smart manufacturing technology and computerized systems within the manufacturing area.
• Department lead of smart manufacturing technology, computerized systems, and Manufacturing Execution System (MES) and represent site on global network initiatives.
• Support Amgen Ohio digital manufacturing team to trouble shoot and develop new ways of working.
• Act as manufacturing business representative in multi-functional meetings and support all levels of the organization to drive digital manufacturing projects.
• First line Subject Matter Expert (SME) for smart manufacturing technology, computerized systems, MES and ERP.
• Assist in global harmonization strategic activities for digital manufacturing which include but not limited to design, improvements, system configuration, validation, and investigations.
• Support key business system lifecycle management and represent team during system upgrades, improvement and maintenance projects.
• Generate, and review documents (SOPs, FORMs, FMEAs, Deviations, CAPA, CC, etc.) associated and owned by digital manufacturing team.
• Work with team to ensure training on new or revised digital manufacturing processes is effective and completed for end-users.(Operators/Supervisors/Technical/QA/Support Staff).
• Actively assist during trouble shoot and apply problem solving skills.
• Uses the latest data analytics tools and methodologies to tackle systematic problems and improve process efficiencies to maintain production schedule alignment.
• Ensure all actions and responsibilities are completed on time and current schedule is maintained, accurate, and up to date, including proactive communication regarding scheduling challenges and provide possible solutions.

We are all different, yet we all use our unique contributions to serve patients. The experienced professional we seek is a collaborative partner with these qualifications.

• High School/GED and 4 years of Manufacturing, Engineering or Computer Science experience.
• Associates Degree and 2 years of Manufacturing, Engineering or Computer Science experience.
• Bachelors Degree and 6 months of Manufacturing, Engineering or Computer Science experience.
• Masters Degree within Manufacturing, Engineering, or Computer Science experience.

• Educational Background or experience in Science, Pharmaceuticals, Biotechnology, Digital Technology, and/or Engineering.
• Experience with design, configuration, qualification/validation in smart manufacturing and computerized systems and system integration supporting manufacturing and the end user on the shop floor (e.g. MES, ERP, SCADA, Systech, Serialization).
• Experience in a GMP environment and background in smart manufacturing technologies and computerized systems and comprehensive understanding of the Manufacturing process with the ability to translate to a System requirements for the end user (ERP and MES).
• Experience in deviations, investigations, root cause analysis, CAPAs and change…