Principal Manufacturing Systems Engineer

Amgen • Cambridge, MA

1d • $160,327 - $216,913

About The Position

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. 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.

Principal Manufacturing Systems Engineer

What you will do
Let’s do this. Let’s change the world. Does the thought of supporting most technologically advanced manufacturing sites globally excite you? Do you love building and developing high performing teams? If you are passionate and want to be a part of Amgen’s mission to serve patients – every patient. Every time – then check out this exciting new opportunity.

In this vital role, you will drive overall program success by applying program and project management principles to teams, partnering with business and technology leaders to ensure comprehensive alignment, and finding optimized ways to deliver efficiency and quality for our partners.

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. Are you someone that has extensive experience on the Operations technology (Aveva Pi, DeltaV, Rockwell, MES) and Program Management to take progressive project management approaches, Are you eager to take your program management, continuous improvement & SAFE-Agile, financial management skills and use them in creative new ways to build groundbreaking Operation smart technologies that helps develop life-changing biotech medicines?, If so, this may be the right place for you.

Requirements

• Doctorate degree and 2 years of Information Systems/Manufacturing Process Automation experience
• Master's degree and 4 years of Information Systems/Manufacturing Process Automation experience
• Bachelor's degree and 6 years of Information Systems/Manufacturing Process Automation experience
• Associate's degree and 10 years of Information Systems/Manufacturing Process Automation experience
• High school diploma / GED and 12 years of Information Systems/Manufacturing Process Automation experience
• Agile methodology authority and traditional waterfall project management methodology

Nice To Haves

• Program/project/product management and delivery experience around manufacturing core systems like Aveva Pi, DeltaV, Rockwell, Korber MES, Digital Infrastructure, Advanced digital smart technologies etc.
• Solid understanding of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards and methodologies, 21 CFR Part 11.
• Fluent in Agile methodologies with respect to technology solutions and their development and timeline.
• Experience as a Product Owner or Scrum Master is preferred.
• Manage integration of OT platforms (MES, PI data etc) with core manufacturing and enterprise systems (ERP, LIMS, historians, automation layers such as DeltaV/Rockwell, and data platforms).
• Strong written and oral communication skills with scientific domain expertise to communicate effectively with various partners within the organization.
• Self-motivated individual with demonstrated ability to learn new concepts and technologies, work multi-functionally in teams (internal and external).
• Project Finance experience.
• Consultant attitude, with the ability to clarify and control a diverse and shifting program lifecycle. Creativity and flexibility will be key components to excelling in this role.

Responsibilities

• 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/product design, deployment, lifecycle management and support to enable scalability and operational excellence.
• Ensure solution delivery meet GMP compliance, data integrity, electronic batch records, and regulatory inspection readiness.
• 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, aligned with business and regulatory requirements.
• Present status updates and progress to senior leadership at various governance meetings.

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Education Level: Ph.D. or professional degree