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# Engineer - System Owner

- **Company:** Amgen
- **Location:** New Albany, OH, United States
- **Experience:** Experienced
- **Salary:** $88,281.0 - $119,439.0
- **Contract:** Permanent contract
- **Skills:** Serialization, Software Design Documents, Desktop Computing
- **Published:** October 19, 2026
- **Apply:** https://www.indeed.com/viewjob?jk=c8aaf4ddf8a27ed4

## About the Role

Master's degree, Bachelor's degree and 2 years of Equipment experience in Pharmaceutical, Medical Devices, Biotechnology, or related industries, Associate's degree and 6 years of Equipment experience in Pharmaceutical, Medical Devices, Biotechnology, or related industries, High school diploma/GED and 8 years of Equipment experience in Pharmaceutical, Medical Devices, Biotechnology, or related industries, * Advanced degree in Mechatronics, Computer, Electrical, Mechanical, or Chemical Engineering

 * Knowledge and/or experience of pharmaceutical/biotech processes, especially in the area of final drug product operations
 * Knowledge of pharmaceutical/biotech processes
 * Familiarity with validation processes for Packaging areas
 * Familiarity with serialization process and networking
 * Familiarity with documentation in a highly regulated environment
 * Ability to operate specialized equipment, tools and computers as appropriate.
 * Ability to interpret and apply GAMPs and GMPs and familiarity with documentation in a highly regulated environment.
 * Ability to apply engineering science to production.
 * Able to develop solutions to routine technical problems of limited scope
 * Comprehensive understanding of protocol requirements.
 * Organizational, project management, problem-solving, as well as validation protocol, and technical writing capability
 * Excellent communication (verbal/written) and presentation skills
 * Demonstrated interpersonal skills including; collaboration, influencing, and facilitation
 * Protocol and script testing Writing
 * Dealing with and handling change
 * Packaging Equipment Technical knowledge
 * Analytical Problem Solving
 * Comprehensive understanding of validation protocol implementation requirements as well as knowledge of validation processes and requirements as applied to new equipment installations
 * Understanding of Operational Excellence and Lean Transformation in the Automation and Engineering Context

## Description

Let's do this. Let's change the world. In this role, the Line Owner/System Owner must work under general supervision, owns all the technical aspects in a manufacturing line. The processes the SO/LO Engineer shall be familiar with are: characterization of process optimization strategies and/or solving problems of operational issues in the packaging operations, manufacturing, pilot technologies or capital projects.

Applies basic engineering principles to the design and implementation of system modifications, experiments and/or capital projects. Organizes, analyzes and presents interpretation of results for operational issues or engineering projects of minor scope and complexity.

As a technical resource of an area, System owner / Line Owner Engineer shall interact and provide direction to technical resources such as Mechanics, Automation Techs and IS teams. At the same time, the System Owner/Line Owner Engineer shall be able to define designs requirement to the service providers to fulfill area technical and equipment needs.

Specific responsibilities include but are not limited to:

 * Provide solutions to a variety of technical problems of moderate scope and complexity.
 * Under general supervision will evaluate, select and apply standard engineering techniques and procedures. Assistance given for unusual problems.
 * Perform assignments that have clear and specific objectives and require investigation of limited number of variables.
 * Initiate and complete routine technical tasks.

Operations Engineering:

 * Function as a technical specialist to equipment or systems regarding problem solving operations. Frequently become actively involved in daily operations when required to meet schedules or to resolve problems.
 * Routinely audit the operational performance and regulatory compliance of a moderate number of equipment items or systems of complexity.
 * Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for system modifications.
 * Design Engineering:
 * Work under the direct supervision of project managers to complete design, engineering, and construction projects within schedule and budget constraints.
 * Work with consultants, architects and engineering firms on development of standard design documents.
 * Acquire and critique quotes for equipment modifications or installations.
 * Generate rudimentary project cost estimates and schedules.