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Amgen Logo Amgen · -

Senior Engineer - Project Engineering

United States, Holly Springs 123098.00 - 149145.00 USD / Year · Job Posted January 10, 2026
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Job Description

The Project Engineer is responsible for providing strategic leadership, technical oversight, and operational management for leading engineering and qualification of small project implementation. This role ensures compliant, efficient, and consistent validation practices across departmental capital projects, site initiatives, and ongoing system lifecycle activities. The position requires strong technical acumen, cross-functional collaboration, and the ability to drive both local and network-level improvements.

Job Responsibility

  • Serve as Qualification Lead for departmental capital projects, overseeing contracted resources, documentation, CCMS assessments, and project alignment
  • Partner with project leads to scope new work, estimate efforts, and assign engineering resources
  • Manage the full lifecycle of the validation maintenance program, including development of the annual scope of work, cost negotiations, PO issuance, and leading progress meetings
  • Drive inspection readiness by maintaining playbooks, responding to inspection IRFs, and presenting qualification topics to auditors
  • Support construction and capital project teams by providing oversight as the role continues to expand
  • Lead efficiency improvements by developing automation/AI tools for periodic reviews and audit trail assessments
  • Participate in global qualification, computerized systems, and data integrity networks and share updates with site teams
  • May own and manage deviations as assigned

Requirements

  • High school diploma / GED and 12 years of Project Implementation and Qualification experience
  • Associate’s degree and 10 years of Project Implementation and Qualification experience
  • Bachelor’s degree and 6 years of Project Implementation and Qualification experience
  • Master’s degree and 4 years of Project Implementation and Qualification experience
  • Doctorate degree and 4 years of Project Implementation and Qualification experience

Nice to have

  • Demonstrated leadership experience in managing technical teams or leading complex cross-functional initiatives
  • Strong understanding of GMP regulations, validation lifecycle requirements, data integrity principles, and qualification best practices
  • Experience serving as a project or qualification lead on capital projects
  • Ability to interface with auditors and respond to regulatory inspection requests
  • Familiarity with automated systems, CCMS/CMMS platforms, and AI/automation tools for compliance workflows
  • Excellent communication, stakeholder engagement, and decision-making skills
  • Ability to manage competing priorities in a dynamic environment and influence without authority
  • Strong analytical skills and ability to translate technical data into clear, actionable insights
  • Prior experience within the pharmaceutical, biotechnology, or regulated life sciences industry strongly desired

What we offer

competitive and comprehensive Total Rewards Plans that are aligned with local industry standards

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