Sr Mechanical Engineer - Manufacturing System Owner

Career Category

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Sr Mechanical Engineer - Manufacturing System Owner

What you will do

Let’s do this. Let’s change the world. Job Description

In this role as Sr. Engineer - System Owner (SO), you will work under general supervision, and own all the technical aspects in a manufacturing line. The processes the SO 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. The SO applies basic engineering principles to the design and implementation of system modifications, experiments and/or capital projects. As a technical resource of an area, the System Owner shall interact and provide direction to technical resources such as Mechanics, Automation Techs and IS teams. At the same time, the System Owner shall be able to define design requirements to the service providers to fulfill area technical and equipment needs.

Specific responsibilities include but are not limited to:

• The work schedule for this role will be an administrative schedule (Monday through Friday, approximately 8 am to 5 pm).
• 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 troubleshooting 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 significant 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.
• Obtain 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 unique contributions to serve patients. The professional we seek will possess these qualifications.

Basic Qualifications:

Doctorate degree

OR

Master’s degree and 2 years of Packaging, Manufacturing, or Automation controls experience

Or

Bachelor’s degree and 4 years of Packaging, Manufacturing, or Automation controls experience

Or

Associate’s degree and 8 years of Packaging, Manufacturing, or Automation controls experience

Or

High school diploma / GED and 10 years of Packaging, Manufacturing, or Automation controls experience

Preferred Qualifications:

• Working knowledge of pharmaceutical/biotech processes
• Packaging Equipment Technical knowledge
• 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 a