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Amgen

Principal Manufacturing Systems Engineer

Amgen

. Lead large capital project and product teams, fostering Agile delivery within GMP manufacturing environments .

Posted 9/24/2026full-timeUnited StatesLead💰 $160,327 - $216,913 per yearWebsite

Core Competencies

Role fit
Core Competencies

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Demonstrates expertise in leading capital projects and product teams within GMP manufacturing environments, ensuring compliance with regulatory standards and effective Agile delivery. Proficient in managing financials, resource planning, and cross-functional collaboration to drive operational excellence.

Highest-signal resume keywords
Agile MethodologiesGMP ComplianceProject ManagementManufacturing Process AutomationCross-Functional Collaboration

ATS Keywords

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Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills
Program ManagementProject DeliveryManufacturing Core SystemsGAMP Software Development LifecycleData IntegrityElectronic Batch RecordsFinancial ComplianceVendor Performance ManagementResource PlanningRegulatory Inspection Readiness
Soft Skills
Strong Communication SkillsConsultant AttitudeCreativityFlexibilityAbility to Learn New Concepts
Tools & Technologies
Aveva PiDeltaVRockwellKorber MESERP IntegrationLIMS IntegrationData PlatformsAutomation LayersDigital InfrastructureAdvanced Digital Smart Technologies
Industry Keywords
GMP ManufacturingANSI/ISA-S88ANSI/ISA-S9521 CFR Part 11Agile PrinciplesLifecycle ManagementGlobal Operations Technology RoadmapBacklog ManagementStakeholder EngagementProgram Lifecycle Control

Tech Stack

Tools & technologies
ERP

About the role

Key responsibilities & impact
  • Lead large capital project and product teams, fostering Agile delivery within GMP manufacturing environments
  • Partner with site and global stakeholders to prioritize demand, manage backlogs, and balance local needs with global strategy
  • Manage financials, resource planning, vendor performance, and delivery against scope, schedule, and quality targets
  • Drive global standards, templates, and best practices for operations technology project/product design, deployment, lifecycle management, and support
  • Ensure solution delivery meets GMP compliance, data integrity, electronic batch records, and regulatory inspection readiness
  • Lead cross-functional collaboration among Operations, Quality, IT, OT, Automation, Platform Owners, and external system integrators
  • Own the global operations technology roadmap, including upgrades, standardization, harmonization, and site deployments
  • Present status updates and progress to senior leadership at governance meetings
  • Lead teams of project managers, platform SMEs, and communications resources
  • Drive financial compliance and adherence across program projects
  • Communicate program status, milestones, and roadmap to executive leadership
  • Ensure product teams operate according to Agile principles and manage backlogs effectively

Requirements

What you’ll need
  • Doctorate degree and 2 years of Information Systems/Manufacturing Process Automation experience, OR Master’s degree and 4 years of experience, OR Bachelor’s degree and 6 years of experience, OR Associate’s degree and 10 years of experience, OR high school diploma/GED and 12 years of experience
  • Program/project/product management and delivery experience around manufacturing core systems such as Aveva Pi, DeltaV, Rockwell, Korber MES, Digital Infrastructure, and advanced digital smart technologies
  • Understanding of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards and methodologies, and 21 CFR Part 11
  • Fluency in Agile methodologies for technology solutions and development timelines
  • Product Owner or Scrum Master experience preferred
  • Experience integrating OT platforms with ERP, LIMS, historians, DeltaV/Rockwell automation layers, and data platforms
  • Strong written and oral communication skills with scientific domain expertise
  • Ability to learn new concepts and technologies and work cross-functionally with internal and external teams
  • Project finance experience
  • Consultant attitude, with ability to clarify and control a diverse and shifting program lifecycle
  • Creativity and flexibility
  • Sponsorship for this role is not guaranteed

Benefits

Comp & perks
  • 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 where possible
  • Career development opportunities
  • Health and welfare plans for staff and eligible dependents
  • Financial plans with opportunities to save towards retirement or other goals
  • Work/life balance