Sr. Mfg Systems Engineer - Serialization System Owner

at  Amgen

HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Sr. Mfg Systems Engineer - Serialization System Owner

BASIC QUALIFICATIONS:

Doctorate degree
Or
Master’s degree and 2 years of Automation experience in Pharmaceutical, Medical Devices or Biotechnology industries
Or
Bachelor’s degree and 4 years of Automation experience in Pharmaceutical, Medical Devices or Biotechnology industries
Or
Associate’s degree and 8 years of Automation experience in Pharmaceutical, Medical Devices or Biotechnology industries
Or
High school diploma/GED and 10 years of Automation experience in Pharmaceutical, Medical Devices or Biotechnology industries

PREFERRED QUALIFICATIONS:

• Advance degree in Computer, Electrical, Mechanical, or Chemical Engineering
• Experience of Systech Suite of products and vision systems for pharma serialization.
• Experience of providing Automation support to pharma manufacturing/packaging systems.
• Ability to build and lead a team for deployment, upgrade and support activities for Systech.
• Ability to troubleshoot SCADA software/hardware issues and provide timely resolution.
• Knowledge and/or experience of pharmaceutical/biotech processes, especially in the area of final drug product operations.
• Knowledge in Data Integrity and Security.
• Extensive understanding and background in programming, design, installation, validation and lifecycle management of manufacturing process controls, automation, field instrumentation technologies.
• Exposure to Machine Vision, Serialization, Robotics, and Rockwell software platform
• Ability to interpret and apply GAMPs and GMPs and familiarity with documentation in a highly regulated environment
• Comprehensive understanding of validation protocol execution requirements as well as knowledge of validation processes and requirements as applied to new equipment installations
• 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
• Strong digital literacy, particularly in Word, Excel, Power Point
• Understanding of Operational Excellence and Lean Transformation in the Automation and Engineering Context

WHAT YOU WILL DO

Let’s do this. Let’s change the world. At Amgen, we are committed to being science-based and follow a continuous learning approach to advancing science, driving discovery and igniting innovation that works to help reduce disease. It is in this context that we endorse an inclusive and diverse workforce that helps fuel scientific innovation and problem solving, leading to better scientific solutions that benefit both patients and society.
Based in New Albany, Ohio, the site of Amgen’s new advanced product assembly and packaging plant this vital role will apply advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, process and/or capital projects.

RESPONSIBILITIES:

• System owner for the serialization system at Amgen Ohio.
• Test and deploy Systech patches and ensure system robustness after patch deployment.
• Troubleshoot and resolve issues with Systech Sentri and Advisor Level systems.
• Work with the IT team to solve serialization issues at the Guardian level.
• Develop training materials related to Systech Serialization.
• Develop, organize, analyze and present interpretation of results for operational issues or engineering projects of significant scope and complexity
• Complete sophisticated or novel assignments requiring development of new and/or improved engineering techniques and procedures.
• Develop detailed specification and engineering policies and procedures that affect multiple organizational units.
• Apply knowledge of engineering principles and practices outside of area of discipline expertise to broad variety of assignments in related fields.
• Work with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing requirements and recommendations for large and/or highly complex system/facility modifications.
• Work with project managers to complete design and engineering projects within schedule, budget and quality constraints.
• Coordinate the work of consultants, architects and engineering firms on development of standard design documents.