Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. 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. Become the professional you are meant to be in this meaningful role.

Sr Engineer

Live

What you will do

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 were 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:

• Available for second or third shifts
• 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 trouble-shooting 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.

Win

What we expect of you

We are all different, yet we all use our outstanding contributions to serve patients. The professional we seek will possess these qualifications.

Basic Education Qualifications:

Doctorate degree

OR

Master’s degree and 3 years of Packaging manufacturing or Automation controls experience

Or

Bachelor’s degree and 5 years of Packaging manufacturing or Automation controls experience

Or

Associate’s degree and 10 years of Packaging manufacturing or Automation controls experience

Or

High school diploma / GED and 12 years of Packaging manufacturing or Automation controls experience

Required/Basic:

• Direct experience with leading and managing Systech Serialization projects including experience with Guardian, Advisor, Sentri, and other Systech ancillary devices.
• Comprehensive understanding of validation protocol execution requirements as well as knowledge of validation processes and requirements as applied to new equipment installations
• Excellent written and verbal skills together with ability to work in a team environment.
• Organizational, project management, problem-solving, as well as validation protocol and technical writing capability
• Track record of leading and performing multi-functional projects.
• Experience in working with third-party vendors and equipment suppliers.
• Ability to work in a highly regulated and ever-changing industry.
• Ability to learn and rapidly adapt to new requirements in a fast paced environment.
• An Operational Excellence and Lean Transformation approach to work product – driving rapid results.
• A passion to deliver an excellent work product and develop others with an infective positive demeanor!

Preferred

• Advance degree in Computer, Electrical, Mechanical, Chemical Engineering, or Biomedical Engineering
• Knowledge and/or experience of pharmaceutical/biotech processes, especially in the area of final drug product operations
• Knowledge in Data Integrity and Security
• Direct experience with medical devices/combination products and associated manufacturing processes.
• Extensive understanding and background in programming, design, installation, validation, and lifecycle management of manufacturing process controls, automation, field instrumentation technologies
• Knowledge in Deep Learning
• Expertise in Machine Vision (Cognex) and Rockwell software platform
• Ability to interpret and apply GAMPs and GMPs and familiarity with documentation in a highly regulated environment
• Experience with Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT)

Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

• Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
• A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor

#NewAlbany2022

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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