MES Application Owner - Systems Engineer

Amgen • Holly Springs, NC

14d

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. MES Application Owner - Systems Engineer What you will do Let’s do this. Let’s 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. You will be 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 new technologies under the challenge of a sophisticated and constantly evolving technology landscape.

Requirements

• Doctorate degree, OR Master’s degree and 2 years of Information Systems, Engineering and/or Information technology experience, OR Bachelor’s degree and 4 years of Information Systems, Engineering and/or Information technology experience, OR Associate’s degree and 8 years of Information Systems, Engineering and/or Information technology experience, OR High school diploma/GED and 10 years of Information Systems, Engineering and/or Information technology experience

Nice To Haves

• Industry experience with utilities/manufacturing software development or management that support manufacturing, (i.e., MES Korber PAS|X, Emerson Delta V, Rockwell, OSISoft PI, VirTECS) preferably biotechnology, pharmaceutical, or related industry.
• Educational background in Computer Science, Engineering, Information Systems, or others related fields.
• 5+ years’ experience designing, developing, deploying, and operating automated solutions across SaaS, Cloud, On-prem and custom software developed platforms.
• Knowledge of 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.

Responsibilities

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

Benefits

• A 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
• Flexible work models, including remote and hybrid work arrangements, where possible

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees