Sr Associate Manufacturing I

Career Category

Job Description

Join Amgen’s Mission of Serving Patients

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

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll 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, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Sr Associate Digital Manufacturing

What you will do

Let’s do this. Let’s 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). Will manage critical processes, provide technical leadership, and be accountable for designing, implementation, and validation of these systems and digital technologies. Responsible for regularly drafting and revision 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 Ohio’s success and key in supporting operations towards the digital future of tomorrow.

Responsibilities may include, but are not limited to:

• 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 networks and initiatives.
• Support the site in the project approvals, prioritization, and manage the roll-out and implementation of smart manufacturing technology concept initiatives for the manufacturing area.
• 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, and MES.
• Assist in global harmonization strategic activities for digital manufacturing which include but not limited to design, improvements, system configuration, validation, and investigations.
• Support digital manufacturing lifecycle management and represent team during software or system upgrades.
• Generate, and review documents (SOPs, FORMs, 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).
• Trouble shoot and assist during problem solving.
• Uses the latest data analysis tools and methodologies to solve 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 errors or issues and provide possible solutions.

What we expect of you

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.

Basic Qualifications:

High School/GED and 4 years of Manufacturing, Engineering or Computer Science experience.

Or

Associate’s Degree and 2 years of Manufacturing, Engineering or Computer Science experience.

Or

Bachelor’s Degree and 6 months of Manufacturing, Engineering or Computer Science experience.

Or

Master’s Degree within Manufacturing, Engineering, or Computer Science experience.

Preferred Qualifications:

• Educational Background or experience in Science, Pharmaceuticals, Biotechnology, Digital Technology, and/or Engineering.
• Experience with design, configuration, qualification/validati