Senior Manufacturing Systems Engineer

Career Category

Job Description

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.

Senior Manufacturing Systems Engineer

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing 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.

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.

Job responsibilities include but are not limited to:

• Own the ongoing creation and roadmap for the Business and Automation platform applications; including system administration, configuration, and maintenance (i.e., Emerson Delta V, Rockwell, Siemens, MES Korber PAS|X, 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

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, 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

Preferred Qualifications:

• 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

• Industry experience with utilities/manufacturing software development or management that support manufacturing, (i.e., Emerson Delta V, Rockwell, Siemens, MES Korber PAS|X, OSISoft PI, VeevaVault, iWAREHOUSE, VirTECS, Autodesk BIM 360) preferably biotechnology, pharmaceutical, or related industry.

• Knowledge with 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

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, we’ll 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

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

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.

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.

Salary Range