Senior Manufacturing Systems Engineer, Holly Springs, NC (US-Local ONLY)

What you will do

HOW MIGHT YOU DEFY IMAGINATION?

Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Senior Manufacturing Systems Engineer ( Holly Springs, NC)

This role only supports US Citizen/Greencard Holders

Live

What you will do

Does the thought of building an entirely new site from the ground up excite you? Do you love cultivating sustainable systems and hard-working teams? If you have a passion for talent development and want to be a part of Amgens mission to serve patients every patient every time then check out this exciting new opportunity.

Amgen, one of the worlds leading biotechnology companies is investing $550 million to build a new multi-product drug substance biomanufacturing facility in Holly Springs, North Carolina, a biomanufacturing hub known for their life sciences industry. The new plant will combine two production formats, traditional stainless steel-fed batch and single use technology. This combination of capabilities is an approach that Amgen calls FleX Batch manufacturing, which makes the facility more dynamic and efficient, as well as requiring a smaller physical footprint than a traditional plant. Additionally, the plant will integrate innovations to advance digitalization and sustainability; aspiring to embed industry 4.0 capabilities and reduce energy consumption and waste generation to meet Amgens plan to be carbon neutral by 2027.

The investment will bring approximately 355 jobs comprised of highly skilled workers that will be built on a foundation that promotes diversity, inclusion and belonging. The site will include the manufacturing plant, warehouse, central utilities, and office space. Amgen is targeting 2024 for site completion.

Lets do this. Lets change the world. In this vital role you will have the outstanding opportunity to support the start-up of the Amgen North Carolina (ANC) manufacturing facility. We are seeking a Senior Manufacturing Systems Engineer to join our Operations Digital Technology and Innovation team. The Senior Manufacturing Systems Engineer collaborates with the Sr. Manager of the Digital Technology and Innovation (DTI) department. The incumbent will be responsible for all activities related to handling and supporting Business and Automation platforms including system administration and technical configuration, system infrastructure architecture; as well as incorporating new technologies under the challenge of a sophisticated and constantly evolving technology landscape.

Responsibilities include:

• Own the ongoing creation and roadmap for the Business and Automation platform applications (i.e. OSI-SOFT PI, MES, DeltaV, Rockwell, Siemens, and other utilities controls platforms), including system administration, configuration, and maintenance.
• Collaborate 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 standard processes.
• 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.
• Collaborate with business partners to understand how automation can improve workflow and productivity.
• Synthesize requirements from end-users, application architects, and cybersecurity experts to develop the best automation solutions.
• Work closely with other business and DTI Manufacturing System Engineers to find opportunities to stop inefficient practices, simplify business processes, and codify into automated solutions and platforms.
• Experience in a GMP regulated environment is required.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek will possess these qualifications.

Basic Qualifications

Doctorate degree OR

Masters degree and 3 years of Information Systems and/or Information technology experience OR

Bachelors degree and 5 years of Information Systems and/or Information technology experience OR

Associates degree and 10 years of Information Systems and/or Information technology experience OR

High school diploma/GED and 12 years of Information Systems and/or Information technology experience

Preferred Qualifications

• Educational background Computer Science, Engineering, Information Systems, or related field
• 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. MES Korber PAS|X, OSISoft PI, VeevaVault, Emerson DELTA V, iWAREHOUSE, VirTECS, Autodesk BIM 360) preferably biotechnology, pharmaceutical, or related industry.
• Knowledge with several Industry 4.0 technologies is a plus 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 complex 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 (OSISoft PI RtReports, Spotfire, Tableau).
• 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 247 operations individually and with vendors
• Experience with Agile Product Development delivery and SAFe practices

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.