Amgen · 1 month ago
Senior Engineer - Project Engineering
Holly Springs, NC
Full-time
Onsite
Mid, Senior Level
4+ years expAmgen is a leading biotechnology company focused on serving patients with serious illnesses. The Senior Engineer - Project Engineering role involves providing strategic leadership and technical oversight for engineering and qualification of small project implementation, ensuring compliant and efficient validation practices.
BiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
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
Qualification
Required
High school diploma / GED and 12 years of Project Implementation and Qualification experience OR
Associate's degree and 10 years of Project Implementation and Qualification experience OR
Bachelor's degree and 6 years of Project Implementation and Qualification experience OR
Master's degree and 4 years of Project Implementation and Qualification experience OR
Doctorate degree and 4 years of Project Implementation and Qualification experience
Preferred
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
Benefits
Competitive and comprehensive Total Rewards Plans
Company
Amgen
Amgen is a biotechnology company that develops and manufactures human therapeutics for various illnesses and diseases.
10001+ employees
H1B Sponsorship
Amgen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (429)
2024 (485)
2023 (485)
2022 (540)
2021 (460)
2020 (444)
Funding
Current Stage
Public CompanyTotal Funding
$28.5B2022-12-12Post Ipo Debt· $28.5B
1983-06-17IPO
Leadership Team
Robert Bradway
Chairman and Chief Executive Officer
Jay Bradner
Executive Vice President of R&D, and Chief Scientific Officer
Recent News
pharmaphorum
2026-01-14
2026-01-13
2026-01-13
Company data provided by crunchbase