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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.

Senior Manufacturing Systems Engineer

What you will do

Let's do this. Let's change the world. In this vital role you will be part of Amgen's newest and most sophisticated final product assembly and packaging plant. The Final Product facility will not only feature the best in-class device assembly and packaging 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.

As a Senior Manufacturing Engineer at Amgen, you will support the analysis, design, and implementation of automation and information systems solutions to meet business requirements. You will collaborate with cross-functional teams to gather and document system requirements, perform system testing, troubleshoot issues, and provide end-user support. Your attention to detail, analytical skills, and strong technical acumen will contribute to the successful delivery of IT projects and the continuous improvement of business processes.

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

Additional Qualifications/Responsibilities

What we expect of you

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

Basic Qualifications:

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

Preferred Qualifications:

BS or MS in computer science, engineering, information systems, or related field

Industry experience with software development of key manufacturing systems such as Supervisory Control or Data Acquisition (SCADA), Systech, FactoryTalk Asset Centre applications that support manufacturing, preferably biotechnology, pharmaceutical, or related industry

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

Experience with Industry 4.0 technologies

Methods and technologies to support Manufacturing Data integrations (e.g. SQL, Web Services/messaging, data mapping)

Data analysis and reporting experience by using analytics, visualization and database technologies (OSISoft PI RtReports, Spotfire, Tableau)

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

Willing and able to learn new technologies at a rapid pace

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

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!

Salary Range

142,955.00 USD - 162,947.00 USD