Senior Manufacturing Systems Engineer

AmgenHolly Springs, NC
Remote

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.

Requirements

  • Bachelor’s degree (or foreign equivalent) in Mechanical Engineering, Engineering or a related field & 4 years of experience in the job offered or in a project management-related occupation.
  • 4 years of experience in Manufacturing Execution System (PASX), MES system enhancements and application upgrades
  • 4 years of experience in Methods and technologies including SQL or Web Services to support Manufacturing Data integrations to enable automated data transfer and electronic batch record (EBR) review by exception
  • 4 years of experience in Current GxP practices, including 21CFR Part 11 requirements in a regulated environment
  • 4 years of experience in Change control process, system validation activities and compliance in computerized system lifecycle management
  • 4 years of experience in Designing, developing, deploying, and operating automated solutions across SaaS, Cloud, On-prem and custom software developed platforms
  • 4 years of experience in Developing technology solutions using agile methodology for improving business-training materials, processes, procedures related to databases, and reporting systems
  • 4 years of experience in Applying business analysis in translating high level business requirements into functional specifications and managing changes to such specifications and modification requests

Responsibilities

  • Own and shape the design and technology of the Manufacturing Information & Technology ecosystem
  • Collaborate with the business partners and other architects to develop a vision and multi-year roadmap for the advancement and lifecycle management of the applications
  • Manage and support the execution of a varied portfolio of IS projects with 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
  • 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 the best automation solutions
  • Work closely with other business and IS Process Engineers to identify opportunities to stop inefficient practices, simplify business processes, and codify into automated solutions and platforms

Benefits

  • stock
  • retirement
  • medical
  • life and disability insurance
  • eligibility for an annual bonus
  • health and welfare plans for staff and eligible dependents
  • financial plans with opportunities to save towards retirement or other goals
  • work/life balance
  • career development opportunities
  • Retirement and Savings Plan with generous company contributions
  • group medical, dental and vision coverage
  • flexible spending accounts
  • discretionary annual bonus program
  • 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
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