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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. 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, 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. We are seeking a Principal Manufacturing Systems Engineer with solid leadership skills in any of Amgen Manufacturing locations in the US or Europe to join our Ops Technology Manufacturing & Engineering team to help drive productivity through the company using technology to unlock opportunities to stop, optimize processes and then automate as appropriate.
Job Responsibility:
Lead large capital project and product teams by fostering Agile delivery while operating within GMP manufacturing environments
Partner with site and global stakeholders to prioritize demand, manage backlogs, and balance local needs with global strategy
Accountable for financials, resource planning, vendor performance, and delivery against scope, schedule, and quality targets
Drive global standards, templates, and best practices for large operations technology project and product design, deployment, lifecycle management, and support
Ensure solution delivery meets GMP compliance, data integrity, electronic batch records, and regulatory inspection readiness requirements
Lead cross-functional collaboration between site and corporate Operations, Quality, IT, OT, Automation, Platform Owners, and external system integrators
Own the global operations technology roadmap, including upgrades, standardization, harmonization, and site deployments
Mentor and coach junior project managers or Scrum Masters
Present status updates and progress to senior leadership at various governance meetings
Requirements:
Doctorate degree and 2 years of Manufacturing automation/Information systems leadership experience
OR Master’s degree and 4 years of Manufacturing automation/Information systems leadership experience
OR Bachelor’s degree and 6 years of Manufacturing automation/Information systems leadership experience
OR Associate’s degree and 10 years of Manufacturing automation/Information systems leadership experience
OR High school diploma / GED and 12 years of Manufacturing automation/Information systems leadership experience
Nice to have:
Program and project management and delivery experience around manufacturing core systems like Aveva PI, DeltaV, Rockwell, Korber MES, Digital Infrastructure, and advanced digital smart technologies
Solid understanding of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards and methodologies, and 21 CFR Part 11
Fluent in Agile methodologies with respect to technology solutions, their development, and timelines
Experience as a Product Owner or Scrum Master
Manage integration of OT platforms (MES, PI data, etc.) with core manufacturing and enterprise systems (ERP, LIMS, historians, automation layers such as DeltaV and Rockwell, and data platforms)
Strong written and oral communication skills with scientific domain expertise
Self-motivated individual with demonstrated ability to learn new concepts and technologies
Project finance experience
Consultant attitude, with the ability to clarify and control a diverse and shifting program lifecycle
Creativity and flexibility
What we offer:
Health and welfare plans for staff and eligible dependents
Financial plans with opportunities to save towards retirement or other goals
Work/life balance
Career development opportunities
Retirement and Savings Plan with generous company contributions