Senior Manufacturing Systems Engineer

at  Amgen

HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? 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. Come do your best work alongside other innovative, driven professionals in this meaningful role.

BASIC QUALIFICATIONS:

• Doctorate degree, OR
• Master’s degree and 3 years of Information Systems, Engineering and/or Information technology experience, OR
• Bachelor’s degree and 5 years of Information Systems, Engineering and/or Information technology experience, OR
• Associate’s degree and 10 years of Information Systems, Engineering and/or Information technology experience, OR
• High school diploma/GED and 12 years of Information Systems, Engineering and/or Information technology experience

PREFERRED QUALIFICATIONS:

• 8+ years’ experience in a manufacturing environment with 5+ years of demonstrated ability in the Pharmaceutical or Biotechnology industries.
• 5+ years’ combined experience with the following product platforms: Data Historian (OSI PI), MES (Korber), Delta V Automation platform, and/or laboratory systems and/or IS platforms.
• Experience and understanding of Information Systems infrastructure services, fundamentals, and operations (Storage, VMs, Network, Active Directory, etc.).
• Experience in methods and technologies to support Manufacturing Data integrations (e.g., SQL, Web Services/messaging, data mapping) is helpful.
• Experience working with Agile development methodologies.
• 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.
• Ability to anticipate, evaluate and resolve multiple, simultaneous project issues, delays and problems by applying technical, project management, and business expertise.
• Proven 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.
• Knowledge of industry standards for SDLC methodologies and 21 CFR Part 11.
• Experience with computer validation and change control methodology.
• Hands-on experience with computerized systems including troubleshooting, reliability, and performance improvements.

WHAT YOU WILL DO

Let’s do this. Let’s change the world. In this vital role you will be accountable for developing and continuously aligning the site manufacturing data ecosystem with rapidly changing business needs and Amgen Digital, Technology & Innovation (DTI) technical roadmaps.
Seeking candidates who possess strong domain expertise in business, and automation systems, information/data management and technical experience in database and data historian technologies and integration tools.

RESPONSIBILITIES:

• Own and craft the design and technology of the DTI ecosystem.
• Be responsible for the execution of a varied portfolio of DTI and automation platforms projects with appropriate portfolio planning, resource, risk management and financial management for the portfolio.
• Crafting Amgen’s future – Keep track of industry and technology trends, connect, and foster external networking opportunities to deliver valuable insight from other similar professionals in our industry!
• Perform cross system analysis, feasibility analysis, scope projects, prioritize deliverables, and recommend optimal solution. Lead multiple initiatives and priorities.
• Effectively manage relationships with DTI service owners, business partners, enterprise DTI service partners, and vendors.
• Accountable to elicit and analyze needs identified by business stakeholders and convert them into functional design.
• Manage DTI platform activities including system administration, troubleshooting, vendor management, platform lifecycle and business requirements.
• Domestic and international travel up to 25%.