• Job Description

  Req#: R-188487

  Career Category

  Information Systems

  Job Description

  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.

  Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations . The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

  Senior Manufacturing Systems Engineer

  Live

  What you will do

  Let’s do this! Let’s change the world! In this vital role a s a Senior Manufacturing Systems Engineer on our Operations Digital , Technology and Innovation team, you will have the outstanding opportunity to support the start-up of the Amgen North Carolina (ANC) manufacturing facility . Y ou will b e responsible for all activities related to managing and supporting Business and Automation platforms including system administration and technical configuration, system infrastructure architecture; as well as incorporating n ew technologies under the challenge of a sophisticated and constantly evolving technology landscape.

  Job responsibilities include but are not limited to:

  • Own the ongoing creation and roadmap for the Business and Automation platform applications ; including system administration, configuration, and maintenance ( i.e., Emerson Delta V, Rockwell, Siemens, MES Korber PAS|X, OSISoft PI, VeevaVault , iWAREHOUSE , VirTECS , Autodesk BIM 360) preferably biotechnology, pharmaceutical, or related industry.

  • C ollaborate with business partners and other technology professionals to develop and deploy the latest, advanced technologies in support of product manufacturing optimization

  • Collaborate with the rest of the manufacturing network to incorporate lessons learned and share ongoing best practices and with the business partners to understand how automation can improve workflow and productivity

  • Manage and/or support the execution of a varied portfolio of DTI projects with appropriate portfolio planning, resource and risk management and financial management for the portfolio

  • Work closely with the delivery and platform teams to ensure that the applications are aligned with standard city planning approved architectural and development guidelines

  • Lead selected efforts to design, build, and develop rapid Proof-of-Concept (POC) automated solutions and services. Quickly and iteratively prove or disprove the concepts being considered

  • Synthesize requirements from end-users, application architects, and cybersecurity experts to develop the best automation solutions

  • Work closely with the business and DTI Manufacturing System Engineers to identify opportunities to stop inefficient practices, simplify business processes, and codify into automated solutions and platforms

  • Ensure all work is completed within GMP regulat ions

  Win

  What we expect of you

  We are all different, yet we all use our unique contributions to serve patients. The systems engineering professional we seek is a dynamic team player with these qualifications.

  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:

  • Educational background in Computer Science, Engineering, Information Systems, or other s related field s

  • 5+ years’ experience designing, developing, deploying, and operating automated solutions across SaaS, Cloud, On-prem and custom software developed platforms

  • Industry experience with utilities/manufacturing software development or management that support manufacturing, ( i.e., Emerson Delta V, Rockwell, Siemens, MES Korber PAS|X, OSISoft PI, VeevaVault , iWAREHOUSE , VirTECS , Autodesk BIM 360) preferably biotechnology, pharmaceutical, or related industry.

  • Knowledge with several industry 4.0 technologies including, but not limited to Process Modeling and Simulation, Data Driven Process Control, Internet of Things, Automated Warehouse solutions, and Automated Guided Vehicles. Methods and technologies to support Manufacturing Data integrations (e.g., SQL, Web Services/messaging, data mapping).

  • Hands-on experience with computerized systems including troubleshooting, reliability, and performance improvements. Experience with Process Design/Configuration and Commissioning.

  • Proficient technical writing and presentation skills to communicate sophisticated information effectively with technical and senior management staff.

  • Expertise with translating business requirements/user stories to technical requirements and recommend solutions for automation.

  • Experience with Data analysis and reporting experience by using analytics, visualization, and database technologies .

  • Experience or solid understanding of current Good Manufacturing Practices (cGMP), 21CFR Part 11 regulations, change control and validation.

  • Willing and able to learn new technologies at a rapid pace

  • Experience in supporting key manufacturing systems with 24×7 operations individually and with vendors

  • Experience with Agile Product Development delivery and SAFe practices

  Thrive

  What you can expect of us

  As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

  The annual base salary range for this opportunity in the U.S. is provided below.

  In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

  • 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 and bi-annual company-wide shutdowns

  • Flexible work models, including remote work arrangements, where possible

  Apply now

  for a career that defies imagination

  Objects in your future are closer than they appear. Join us.

  careers.amgen.com

  #AmgenNorthCarolina

  .

  Salary Range

  135,728.00 USD - 159,431.00 USD

• About the company

  Amgen is one of the world’s leading biotechnology companies. Amgen is a values-based company, deeply rooted in science and innovation to transform new ideas and discoveries into medicines for patients with serious illnesses.

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