Sr Mfg Systems Engineer

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll 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

Lets do this. Lets 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

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
Masters degree and 2 years of Information Systems job experience in a GMP environment
OR
Bachelors degree and 4 years of Information Systems job experience in a GMP environment
OR
Associates 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!

What you can expect from us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include:

• 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

Apply now

for a career that defies imagination

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

careers.amgen.com

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Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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, disability status, or any other basis protected by applicable law.

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 is an Equal

Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Salary Range