Senior Manufacturing Systems Engineer
About the role
At Amgen, 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 toughest diseases. With a 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.
Responsibilities
- Own and shape the design and technology of the Manufacturing Information & Technology ecosystem.
- Collaborate with business partners and other architects to develop a vision and multi-year roadmap for the advancement and lifecycle management of applications.
- Manage and support the execution of a varied portfolio of IS projects with portfolio planning, resource and risk management, and financial management.
- Work closely with delivery and platform teams to ensure applications align with standard architectural and development guidelines.
- Lead selected efforts to design, build, and develop rapid Proof-of-Concept (POC) automated solutions and services.
- Collaborate with business partners to understand how automation can improve workflow and efficiency.
- Synthesize requirements from end-users, application architects, and cybersecurity experts to develop optimal automation solutions.
- Work with other business and IS Process Engineers to identify opportunities to eliminate inefficient practices, simplify processes, and codify them into automated solutions.
Requirements
Bachelor’s degree (or foreign equivalent) in Mechanical Engineering, Engineering, or a related field, plus 4 years of experience in the job offered or a project management-related occupation. Position requires 4 years of experience in the following:
- Manufacturing Execution System (PASX), MES system enhancements, and application upgrades.
- Methods and technologies including SQL or Web Services to support Manufacturing Data integrations for automated data transfer and electronic batch record (EBR) review by exception.
- Current GxP practices, including 21CFR Part 11 requirements in a regulated environment.
- Change control process, system validation activities, and compliance in computerized system lifecycle management.
- Designing, developing, deploying, and operating automated solutions across SaaS, Cloud, On-prem, and custom software-developed platforms.
- Developing technology solutions using agile methodology to improve business-training materials, processes, procedures related to databases, and reporting systems.
- Applying business analysis in translating high-level business requirements into functional specifications and managing changes to such specifications and modification requests.
May telecommute.
Pay
The annual salary range for this position in the U.S. is $142,955.00 – $165,280.00 per year.
Benefits
- Stock-based long-term incentives.
- Retirement and Savings Plan with generous company contributions.
- Group medical, dental, and vision coverage.
- Life and disability insurance.
- Flexible spending accounts.
- Discretionary annual bonus program (or sales-based incentive plan for field sales roles).
- Award-winning time-off plans.
- Flexible work models, including remote and hybrid work arrangements where possible.
For more details, visit Amgen Benefits.