Principal Manufacturing Systems Engineer

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.

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.

A day in the life:

• You are leading from the front engaging with business functions across the company to help deliver core manufacturing systems.

• Partnering with strategy group at Amgen and business partners to deliver initiatives.

• Lead a team of PM’s, Platform SME’s, Communication resources to ensure structure of how we operate within the program.

• Drive financial compliance/adherence of the program via the various projects.

• Own overall Program roadmap and communicate program status/milestones to executive leadership.

• Ensure product teams operate in the spirit of Agile and have backlogs that are being handled optimally.

• What we expect of you

• We are all different, yet we all use our unique contributions to serve patients. The Project manager, Program manager, Product Owner or Scrum Master professional we seek is an Agile methodology authority and traditional waterfall project management methodology with these qualifications.

Basic Qualifications:

• Doctorate degree and 2 years of Information Systems/Manufacturing Process Automation experience

• OR

• Master’s degree and 4 years of Information Systems/Manufacturing Process Automation experience

• OR

• Bachelor’s degree and 6 years of Information Systems/Manufacturing Process Automation experience

• OR

• Associate’s degree and 10 years of Information Systems/Manufacturing Process Automation experience

• OR

• High school diploma / GED and 12 years of Information Systems/Manufacturing Process Automation experience

Preferred Qualifications:

• 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 t

• Industry: Healthcare