Packaging Equipment Engineer - System Owner

HOW MIGHT YOU DEFY IMAGINATION?

Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Engineer - System Owner - Packaging Equipment Engineer

Live

What you will do

Lets do this. Lets 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:

• The original work schedule for this role will be an administrative schedule (Monday through Friday, approximately 8 am to 5 pm). As the facility moves into operation, the successful incumbent will be encouraged to join a shift team structure working to support coverage across Amgens 24-hour operations. These shift structures can be an outstanding opportunity to better support individual work / life priorities.
• 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.

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 Qualifications:

Masters degreeOrBachelors degree and 2 years of Equipment experience in Pharmaceutical, Medical Devices, or Biotechnology industriesOrAssociates degree and 6 years of Equipment experience in Pharmaceutical, Medical Devices, or Biotechnology industriesOrHigh school diploma/GED and 8 years of Equipment experience in Pharmaceutical, Medical Devices, or Biotechnology industries

Preferred Qualifications:

• 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

Thrive

Some of the vast rewards of working here

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

This position will be paid on an hourly basis. The annualized base pay range for this opportunity in the U.S. is $40.80 to $49.87.

In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

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

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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 cancers, 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.