Principal Manufacturing Systems Engineer

Amgen

Principal Manufacturing Systems Engineer leveraging program management and operational technology to improve biotech manufacturing at Amgen. Collaborating with cross-functional teams to enhance efficiency and quality standards.

Posted 5/8/2026full-timeCalifornia, Massachusetts, North Carolina, Ohio, Rhode Island • 🇺🇸 United StatesLead💰 $NaN per yearWebsite

Tech Stack

Tools & technologies

ERP

About the role

Key responsibilities & impact

Lead large capital project and product teams by fostering Agile delivery while operating within GMP manufacturing environments.
Partner with site and global stakeholders to prioritize demand, manage backlogs, and balance local needs with global strategy.
Accountable for financials, resource planning, vendor performance, and delivery against scope, schedule, and quality targets.
Drive global standards, templates, and best practices for large operations technology project and product design, deployment, lifecycle management, and support to enable scalability and operational excellence.
Ensure solution delivery meets GMP compliance, data integrity, electronic batch records, and regulatory inspection readiness requirements.
Lead cross-functional collaboration between site and corporate Operations, Quality, IT, OT, Automation, Platform Owners, and external system integrators.
Own the global operations technology roadmap, including upgrades, standardization, harmonization, and site deployments, aligned with business and regulatory requirements.
Mentor and coach junior project managers or Scrum Masters.
Present status updates and progress to senior leadership at various governance meetings.

Requirements

What you’ll need

Doctorate degree and 2 years of Manufacturing automation/Information systems leadership experience OR
Master’s degree and 4 years of Manufacturing automation/Information systems leadership experience OR
Bachelor’s degree and 6 years of Manufacturing automation/Information systems leadership experience OR
Associate’s degree and 10 years of Manufacturing automation/Information systems leadership experience OR
High school diploma / GED and 12 years of Manufacturing automation/Information systems leadership experience
Program and project management and delivery experience around manufacturing core systems like Aveva PI, DeltaV, Rockwell, Korber MES, Digital Infrastructure, and advanced digital smart technologies.
Solid understanding of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards and methodologies, and 21 CFR Part 11.
Fluent in Agile methodologies with respect to technology solutions, their development, and timelines.
Experience as a Product Owner or Scrum Master is a must.
Manage integration of OT platforms (MES, PI data, etc.) with core manufacturing and enterprise systems (ERP, LIMS, historians, automation layers such as DeltaV and Rockwell, and data platforms).
Strong written and oral communication skills with scientific domain expertise to communicate effectively with various partners within the organization.
Self-motivated individual with demonstrated ability to learn new concepts and technologies and work cross-functionally in teams, both internal and external.
Project finance experience.

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
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.

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Manufacturing automationInformation systems leadershipProgram managementProject managementGAMP software development lifecycleAgile methodologiesProduct OwnerScrum MasterIntegration of OT platformsProject finance

Soft Skills

LeadershipMentoringCommunicationCollaborationSelf-motivatedCross-functional teamworkPresentation skillsStakeholder managementResource planningProblem-solving