Principal Manufacturing Systems Engineer

Join Amgens Mission of Serving Patients
At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnesses drives all that we do.

Lets do this. Lets change the world. In this vital role, you will be part of Amgen's most technologically advanced drug substance manufacturing plant. The facility continues to expand in size and advance with embedded new technologies and industry 4.0 capabilities facility wide.

As a Principal Manufacturing Systems Engineer, You Will

• Own the successful delivery of varied portfolio of IS/Automation projects with appropriate portfolio planning, resource and risk management and financial management for the portfolio.
• Ability to anticipate, evaluate and resolve multiple, simultaneous project issues, delays, and problems by using technical, project management, and business expertise.
• Performs cross system assessments, feasibility analysis, scope projects, prioritize work you're doing, and recommend optimal solution. Manage multiple initiatives and priorities.
• Ability to translate strategic opportunities and emerging technology solutions into tangible pragmatic executable plans allied to the ability to apply corporate blueprint and standards using business drivers to local business needs and project requirements.
• Effectively manage relationships with Peers, IS service owners, business partners, enterprise IS service partners, and vendors.
• Communicates with multiple levels within the organization, highlighting issues and proposing solutions.
• Accountable to elicit and analyze needs identified by business customers and convert them into functional design.

We are all different, yet we all use our unique contributions to serve patients. The manufacturing technology professional we seek is an innovator with these qualifications.

Doctorate degree and 2 years of Information Systems, Manufacturing Process automation/Information system experience

OR

Master's degree and 4 years of Information Systems, Manufacturing Process automation/Information system experience

OR

Bachelor's degree and 6 years of Information Systems, Manufacturing Process automation/Information system experience

OR

Associate's degree and 10 years of Information Systems, Manufacturing Process automation/Information system experience

OR

High school diploma / GED and 12 years of Information Systems, Manufacturing Process automation/Information system experience

• Demonstrable experience in a manufacturing environment with ability in the Pharmaceutical or Biotechnology industries.
• Experience with the following product platforms:
  Automation/Process Control System (PCS), Data Historian and/or Manufacturing Execution System (MES) and/or laboratory systems and/or IS platforms.
• Position requires an in-depth knowledge and hands‑on coding experience of Emerson Delta V Platform in particular, and on Rockwell Factory Talk, Rockwell PLCs. Aveva PI Data Historian knowledge is required.
• Kneat platform based C&Q documentation development knowledge a plus
• Additional experience with Korber MES is a plus.
• Demonstrable understanding of GAMP software development lifecycle, ANSI/ISA‑S88 and S95 industry standards and methodologies to establish a PCS and MES implementation and Systems Integration that meets Operations' business requirements.
• Exposure to sophisticated technologies around PAT, APC, AR/VR, Location tracking, Control tower, IIoT, IDA and so on would be an advantage.
• Familiarity with industry standards for software development life cycle methodologies and 21 CFR Part 11
• Experience with validation and change control methodology.
• Hands‑on experience…