Senior Manufacturing Systems Engineer

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.

Responsibilities

• Technical support during Capital Projects implementation including documentation review, approval, technical advice, troubleshooting.
• Willing to travel to other Amgen sites to support Capital Projects (50%) including temporary short-term relocations.
• Own the ongoing creation and roadmap for key manufacturing systems.
• Collaborate with business partners and other technology professionals to develop, deploy, and maintain 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.
• Manage and/or support the execution of a varied portfolio of IS 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.
• Technical support to manufacturing operations.
• Work closely with other business and IS Process Engineers to find opportunities to stop inefficient practices, simplify business processes, and codify into automated solutions and platforms.

Requirements

• Doctorate degree OR Master’s degree and 2 years of Information Systems job experience in a GMP environment OR Bachelor’s degree and 4 years of Information Systems job experience in a GMP environment OR Associate’s degree and 8 years of Information Systems job experience in a GMP environment OR High school diploma / GED and 10 years of Information Systems job experience in a GMP environment.
• Master’s degree OR Bachelor’s degree and 2 years of Information Systems job experience in a GMP environment OR Associate’s degree and 6 years of Information Systems job experience in a GMP environment OR High school diploma / GED and 8 years of Information Systems job experience in a GMP environment.

Nice-to-haves

• BS or MS in computer science, engineering, information systems, or related field.
• 5+ years’ experience designing, developing, deploying, and operating automated solutions across Cloud, On-prem and custom software developed platforms.
• Experience with several Industry 4.0 technologies is a plus.
• Vast knowledge on Swisslog SynQ Warehouse Management System and the application integration with SAP Extended Warehouse Management (SAP EWM).
• Industry experience with software development of key manufacturing systems such as Rockwell FactoryTalk, PAS-X MES, AVEVA PI, Siemens Desigo and SAP EWM applications that support manufacturing, preferably biotechnology, pharmaceutical, or related industry.
• Hands-on experience with computerized systems including troubleshooting, reliability, and performance improvements.
• Expertise with translating business requirements/user stories to technical requirements and recommend solutions for automation.
• Experience in supporting key manufacturing systems with 24x7 operations individually and with vendors.
• Experience or solid grasp of current Good Manufacturing Practices (GMP), 21CFR Part 11 regulations, change control, validation.
• Experience with Agile Product Development delivery and SAFe practices.
• Methods and technologies to support Manufacturing Data integrations (e.g. SQL, Web Services/messaging, data mapping).
• Willing and able to learn new technologies at a rapid pace.
• Knowledge in Data Integrity and Security.
• Comprehensive understanding of validation protocol execution requirements as well as knowledge of validation processes.
• Excellent written and verbal communication skills together with demonstrated ability to work in a team environment.
• Organizational, problem-solving, as well as validation protocol and technical writing capability.
• Proven track record of leading and executing cross-functional projects.
• Strong teamwork, excellent interpersonal and communication skills.
• Experience in working with third-party vendors and equipment suppliers.
• Ability to work in a highly regulated and ever-changing industry.
• Ability to learn and rapidly adapt to new requirements in a fast-moving environment.
• A passion to deliver an excellent work product and develop others with an infective positive attitude!

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.