Amgen · 14 hours ago
Mfg Systems Engineer - System Owner
US - Ohio - New Albany
Full-time
Onsite
Mid, Senior Level
$118K/yr - $134K/yr
2+ years expAmgen is a leading biotechnology company focused on serving patients with serious illnesses. The Mfg Systems Engineer - System Owner will design, implement, and optimize automation systems to support packaging and manufacturing operations, ensuring safety, quality, and efficiency across multiple lines.
BiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Design, develop, implement, and sustain automation, control, and mechanical systems supporting packaging and manufacturing operations
Serve as System Owner for assigned equipment and systems, accountable for system performance, reliability, lifecycle management, and regulatory compliance
Apply established engineering principles and Amgen standards to system design, configuration, modification, and continuous improvement activities
Develop, review, and approve system documentation including URS, specifications, design documents, SOPs, and lifecycle records
Provide technical requirements and direction to vendors, service providers, and internal partners
Integrate new automation technologies into existing manufacturing and packaging systems
Support process characterization, optimization, and performance monitoring to improve throughput, quality, and operational efficiency
Act as a technical authority (SME) for assigned systems, supporting routine operations and issue resolution
Conduct feasibility assessments, risk evaluations, and cost-benefit analyses for system enhancements
Provide advanced trouble shooting and problem-solving support for automation systems and equipment
Collaborate with Maintenance, Automation Technicians, Manufacturing, IS, and Quality to resolve issues and minimize downtime
Lead root cause investigations and support development and implementation of corrective and preventive actions
Plan and execute system upgrades, obsolescence mitigation, and reliability improvements
Ensure systems operate in compliance with GMP, GAMP, data integrity, and regulatory requirements
Support validation lifecycle activities including protocol development, execution, and reporting (IQ, OQ, PQ)
Maintain validated state of assigned systems and support regulatory inspections and audits
Partner with Quality, Validation, and Regulatory Affairs to address compliance-related issues
Lead or support automation-related capital and expense projects in alignment with site and network priorities
Coordinate with project managers, vendors, and engineering firms to deliver solutions within defined scope, schedule, and budget
Develop technical assessments, cost estimates, schedules, and project documentation
Communicate project status, risks, and performance metrics to stakeholders
Reverse engineer equipment and parts
Provide technical guidance, coaching, and knowledge transfer to operations and maintenance personnel
Develop and deliver training materials to support effective operation and maintenance of systems
Support commercial packaging operations by providing timely technical support and driving continuous improvement initiatives
Demonstrate Amgen leadership behaviors through collaboration, accountability, and continuous learning
Lead and execute reverse engineering activities including dimensional analysis, material identification, functional assessment, and design recreation using CAD, 3-D scanning technologies, and engineering analysis tools
Develop, review, and approve engineering models, drawings, and specifications for reverse-engineered parts in accordance with Amgen engineering standards and GMP requirements
Maintain reliability of additive manufacturing (3-D printing) for spare parts, fixtures, tooling, and non-product contact components, including risk, material compatibility, mechanical performance, and regulatory impact
Establish and maintain documentation required to support 3-D printed parts, including design records, material certifications, inspection results, and traceability documentation
Develop lifecycle strategies for digitally stored spare parts (digital inventory), including version control, cybersecurity considerations, and long-term accessibility
Provide technical guidance and training to Engineering, Maintenance, and Operations teams on reverse engineering methods, 3-D scanning technologies, and additive manufacturing standard methodologies
Own the end-to-end 3-D printing process for approved use cases, including: Functional equivalency, Technology and material selection, Printer and scanner qualification and maintenance, Print parameter definition and optimization, Post-processing, inspection, and acceptance criteria
Qualification
Required
Master's degree
Bachelor's degree and 2 years of relevant Automation, Packaging, or Manufacturing experience
Associate's degree and 4 years of relevant Automation, Packaging, or Manufacturing experience
High school diploma / GED and 8 years of relevant Automation, Packaging, or Manufacturing experience
Preferred
Advanced degree in Engineering (Mechatronics, Electrical, Computer, Mechanical, or Chemical)
Experience in pharmaceutical or biotechnology manufacturing environments
Demonstrated System Owner or technical system lead experience
Knowledge of PLC/HMI programming and industrial automation platforms (e.g., Rockwell, Siemens)
CSWA certification for SolidWorks. Inventor and Fusion 360 proficiency
Understanding of validation, documentation, and change management in regulated environments
Strong analytical, problem-solving, communication, and collaboration skills
Familiarity with Operational Excellence and Lean principles
Benefits
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.
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
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