Principal Manufacturing Systems Engineer at Amgen - ScoutJobs - The AI-curated global job board
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Amgen
Posted a month ago

Principal Manufacturing Systems Engineer

AmgenPrincipal Manufacturing Systems Engineer

Perks & benefits

Health InsuranceMedical Insurance

Requirements

Manufacturing automation leadership experience, Information systems leadership experience, Agile methodologies, Product Owner or Scrum Master experience, GAMP software development lifecycle knowledge, ANSI/ISA-S88 and S95 standards, 21 CFR Part 11 compliance

Skills

DeltaVRockwellMESAgileGMP

About the role

Responsibilities

  • Lead large-scale capital projects and product teams using Agile delivery within GMP manufacturing environments
  • Partner with site and global stakeholders to prioritize demand, manage backlogs, and align local needs with global strategy
  • Manage financials, resource planning, vendor performance, and delivery against scope, schedule, and quality targets
  • Drive global standards and best practices for operations technology project design, deployment, and lifecycle management
  • Ensure solution delivery meets GMP compliance, data integrity, and regulatory inspection readiness requirements
  • Lead cross-functional collaboration between Operations, Quality, IT, OT, and external system integrators
  • Own the global operations technology roadmap, including upgrades, standardization, and site deployments
  • Mentor and coach junior project managers and Scrum Masters

Requirements

  • Extensive experience in manufacturing automation or information systems leadership
  • Proven experience with operations technology such as Aveva Pi, DeltaV, Rockwell, or MES
  • Experience working within a GMP manufacturing environment
  • Strong leadership skills to manage complex, large-scale technical programs

Preferred Qualifications

  • Experience as a Product Owner or Scrum Master
  • Deep understanding of GAMP software development lifecycle and 21 CFR Part 11 compliance
  • Knowledge of ANSI/ISA-S88 and S95 industry standards
  • Proficiency in Agile methodologies applied to technology solutions
  • Experience integrating OT platforms with enterprise systems like ERP and LIMS
  • Strong project finance and program management expertise

Benefits

  • Comprehensive health, dental, and vision coverage
  • Retirement and savings plans with company contributions
  • Discretionary annual bonus program
  • Stock-based long-term incentives
  • Award-winning time-off plans

About the Company

Amgen is a leading biotechnology company dedicated to serving patients living with serious illnesses. Since 1980, we have pioneered advancements in oncology, inflammation, general medicine, and rare diseases to help people live longer, fuller, and happier lives.

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Principal Manufacturing Systems Engineer

Amgen · Thousand Oaks

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