Principal Manufacturing Systems Engineer

Amgen

Remote Actively hiring
Thousand Oaks, CA · Holly Springs, NC · Cambridge, MA · West Greenwich, RI · New Albany, OH Posted 22 days ago

At a glance

AI generated

TL;DR

As a Principal Manufacturing Technology and Information Systems Engineer at Amgen, you will lead large-scale capital projects and product teams within GMP manufacturing environments, leveraging Agile methodologies to optimize processes and automate systems. You will collaborate with global stakeholders to prioritize initiatives, manage financials, and ensure compliance with regulatory standards such as 21 CFR Part 11 and GAMP guidelines. Your responsibilities include driving the development of global operations technology roadmaps, mentoring junior project managers, and presenting progress to senior leadership. Preferred qualifications include experience with manufacturing systems like Aveva PI, DeltaV, Rockwell, and MES, along with a solid understanding of Agile methodologies and financial management in pharmaceutical settings. This role demands expertise in program management, continuous improvement, and the ability to work cross-functionally across various departments to deliver groundbreaking operational technologies that enhance efficiency and quality in biotech manufacturing.

Skills

Aveva_PI DeltaV Rockwell MES Agile GAMP ANSI/ISA-S88 21_CFR_Part_11 ERP LIMS Scrum CI/CD Kubernetes AWS Terraform Python PostgreSQL

What you'll do

  • Lead large capital project teams using Agile methodologies within GMP environments.
  • Manage financials, resources, and vendor performance for technology projects.
  • Drive global standards and best practices for operations technology projects.
  • Ensure solution delivery meets GMP compliance and regulatory inspection readiness.
  • Own the global operations technology roadmap and communicate progress to leadership.
  • Mentor junior project managers or Scrum Masters in Agile methodologies.
  • Lead cross-functional collaboration between site and corporate teams on initiatives.

What we're looking for

  • Extensive leadership experience in manufacturing automation/Information systems.
  • Proven track record in program and project management for core manufacturing systems.
  • Solid understanding of GAMP, ANSI/ISA-S88, S95 standards, and 21 CFR Part 11 compliance.
  • Fluent in Agile methodologies with product ownership or Scrum Master experience.
  • Expertise in integrating OT platforms (MES, PI data) with enterprise systems (ERP, LIMS).
  • Strong communication skills for cross-functional collaboration within the organization.
  • Demonstrated ability to manage financials and deliver projects under GMP compliance.

Market check

Salary context

This listing doesn't show a salary. Similar roles on FindRole typically pay $136,000–$216,913.

Peer median band

$136,000$216,913

Median floor and ceiling across peers.

Typical midpoint (25–75%)

$143,248$216,250

Middle half of comparable postings.

Based on 239 comparable postings.

* 240 is the maximum number of comparable postings sampled.

Employer

About Amgen

Amgen is a leading biotechnology company that discovers, develops, manufactures, and delivers innovative human therapeutics, with products addressing conditions such as anemia, bone loss, inflammation, and cancer. Industry: Biotechnology & Pharmaceuticals

Amgen currently has 23 open roles on FindRole.

Listed pay typically runs $131,708–$173,047 across 22 roles with salary data.

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