Automation Engineer - AML7 Drug Substance

SUMMARY

Are you looking for a challenging new opportunity to test and growth your Engineering and/or Automation skills?

We are looking for two Automation Engineers that with general supervision will provide characterization of process optimization strategies and troubleshooting of issues in the manufacturing, pilot plant and/or capital projects environment in the second and third shift operations. As part of a non-standard rotating shift, the team focuses in apply 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 and/or low complexity engineering projects. This role is crucial for Amgen's success and it will be a key contributor in the AML 7 Drug Substance organization.

THE DEPARTMENT

The AML-7 Facility is the home of elite, multi-product Microbial Drug Substance Manufacturing Operations. The facility highlights the combination of groundbreaking manufacturing sciences and process technology, advanced equipment engineering and automation, and a culture of opportunities integrating cross-functional teams from across the site with the goal of achieving being the best drug substance manufacturing facility in the world.

SPECIFIC RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:

• Provide solutions to a variety of technical problems various complexity.
• Under general supervision will evaluate, select and apply standard engineering techniques and procedures.
• Perform assignments that have clear and specific objectives and require investigation of limited number of variables.
• Initiate and complete routine technical tasks.
• Prompt and regular attendance to workplace.
• Function as a technical expert to automation 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.
• Work with Research, Manufacturing, Maintenance, Process Development, Utilities, Facilities, Quality Assurance and/or Validation departments in developing requirements and recommendations for system modifications.

• Obtain and assess quotes for equipment modifications or installations.
• Generate project budgetary estimates and schedules.
• Develop process control applications utilizing Programmable Logic Controllers (PLC), Distributed Control Systems, Human Machine Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA).
• Familiarity with industry standards for batch control systems, software development life cycle methodologies, 21 CFR Part 11, and GAMP.
• Develop specification, engineering documents and standards operating procedures.
• Troubleshoot and resolve equipment, automation or process issues in the field.

EDUCATION/LICENSES

Master's degree in Engineering

OR

Bachelor's degree in Engineering & 2 years of Engineering or Automation experience.

PREFERRED QUALIFICATIONS

• Background in programming, design, installation and lifecycle management of manufacturing process controls, automation and field instrumentation technologies.
• Working knowledge of pharmaceutical/biotech processes.
• Familiarity with computer validation processes and documentation in a highly regulated environment.
• Strong verbal communication skills in English and Spanish.
• Skills in the following areas:
  • Problem solving and applied engineering
  • Basic technical report writing
  • Basic technical presentations
  • Personal Organization
  • Validation Protocol Writing
  • Dealing with and managing change
  • Technical (Software Specific)
  • Analytical Problem Solving
  • Computer Literacy (MS Office Suite, Power BI, SharePoint, Spotfire, etc...)
• Knowledge on Rockwell Automation Platform and Allen-Bradley PLCs.
• Work schedule flexibility to support 24/7 operations.
• Knowledge of ASTM 2500, ISA S88 and S95 techniques. - Batch processing a desired advantage.
• Knowledge in programming language (e.g. VBA)

Amgen is committed to unlock the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.

Amgen focuses on areas of high unmet medical need and uses its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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.