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Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Specialist Manufacturing

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will supports two Drug Substance facilities and serves a critical role in Amgen’s commercial manufacturing network. The successful candidate will be responsible for ownership and oversight of the MES system at ARI. The successful candidate will have five to ten years of experience in a pharmaceutical or biotech industry and will have demonstrated competency in leading projects and teams to deliver MES designs within project timelines. This role is a key communication and technical interface for the ARI Drug Substance facilities

Manufacturing Execution Systems (MES) Lead will be responsible for the design, authoring, implementation and validation of the Electronic Batch Records used in the plants. Responsible for the development, configuration and testing of Master Batch Records (MBRs) from initial to final design. Provide business oversight of the MES system across the site.

• Represents the plant on global MES network and initiatives
• Liaison with Amgen MES core-team to troubleshoot and develop new ways of working.
• Responsible for the support and ongoing development of the Amgen MES system in development of MBRs and improving the MES business process.
• Responsible for drafting, executing and reviewing Application Lifecycle Management test scripts and test sets for testing MBR design
• Responsible for training of Electronic Batch Record (EBR) end-users (Supervisors, Operators, Technical/QA/Support staff)
• Responsible for any applicable equipment integration design, configuration and testing to allow MBR interaction with shop floor equipment - OSI PI, Recipe Managers - DeltaV
• Responsible for resolving interface errors and stock discrepancies between ERP/MES as required.
• Responsible for leading MBR development design reviews including liaising with Operations, Process Development and Quality functions
• Responsible for providing technical support where required and as directed by Operations leadership

Project Management and Team Building

• Experience in cross functional Project Management
• Manage multiple assignments and processes
• Independently determine approach to projects
• Independently develop solutions that are thorough, practical and consistent with functional objectives
• Partners and communicates effectively with other departments and support functions to ensure positive working relationships.
• Extends capabilities by working closely with senior staff / experts within and outside organization
• Ability to coach, mentor and/or cross train colleagues within core technical areas

Compliance and Quality

• Own and manage deviations, corrective actions and change controls related to MES and related areas
• Contribute to and assist with Corporate, FDA, and other regulatory bodies during company audits
• Collaborate with Regulatory and Quality partners to manage change control records and respond to regulatory questions and/or audit findings associated with MES in the plant
• Accountable for the safe operation of the area ensuring all safety policies are adhered to and that any incidents are reported in a timely manner. Promotes a positive safety culture

Win

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:

• Master’s degree in Engineering or Science and 3 years of Manufacturing experience Or
• Bachelor’s degree in Engineering or Science and 5 years of Manufacturing experience Or
• Associate’s degree in Engineering or Science and 10 years of Manufacturing experience

Preferred Qualifications:

• Broad technical experience in MES systems
• Experience with PAS X, Werum software
• Experience of working in bulk manufacturing operations or have a demonstrated capacity to learn quickly and adapt to new technology
• The ability to adapt quickly to the demands of commercial manufacturing operations
• Extensive experience with electronic documentation systems in a regulated environment
• Working knowledge of manufacturing in pharmaceutical/biotech industries
• Knowledge of regulation requirements (GMP & GAMP)

Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

• Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
• A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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