Amgen Senior Automation Engineer in New Albany, Ohio
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.
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.
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.
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.
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:
Master’s degree and 3 years of Packaging manufacturing or Automation controls experience
Bachelor’s degree and 5 years of Packaging manufacturing or Automation controls experience
Associate’s degree and 10 years of Packaging manufacturing or Automation controls experience
High school diploma / GED and 12 years of Packaging manufacturing or Automation controls experience
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!
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)
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
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.