Sr. Automation Engineer - AML6 Drug Substance

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.

Senior Automation Engineer - AML6 Drug Substance

Multiple Positions Available

Live

What you will do

Let's do this. Let's change the world! In this vital role the Sr. Automation Engineer will apply the advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, troubleshooting, process and/or capital projects. You will also develop, prioritize, analyze and present interpretation of results for operational issues or automation/engineering projects of significant scope and complexity. Your deep understanding of the big picture will be vital as you help to develop deviation documents, and craft even-more efficient methods and processes around the AML6 Drug Substance facility. In addition this role will assist the team delivering training, sharing knowledge and even may lead responsibilities within the work team in a non-standard shift operation. Specific responsibilities include but are not limited to:
  • Develop engineering policies and specifications, operating standards and procedures (SOP's) that affect multiple organizational units.
  • Apply knowledge of engineering principles and practices outside of area of expertise to broad variety of assignments in related fields.
  • Serve as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area.
  • Work closely with multiple functional areas to implement operational improvements and in developing requirements and recommendations for large and/or highly sophisticated system/facility modifications.
  • Lead technical root cause analysis, incident investigations, and troubleshooting on process control issues related to instrumentation and control systems.
  • Support new product or new technology introductions by performing engineering assessments, implementing automation system configuration changes and supporting engineering runs.
  • Design, installation, programming and validation of automated processes.
  • Work with project managers to complete design and engineering projects within schedule, budget and quality constraints.
  • Application of mature engineering knowledge in planning and conducting projects.
  • Lead, delegate and/ or coordinate the work of consultants, architects and engineering firms on development of standard design documents.
  • Develop technical solutions to complicated problems requiring the regular use of creativity.
  • Develop process control applications utilizing Batch, Programmable Logic Controllers (PLC), Distributed Control Systems, Human Machine Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA).
  • Support non-standard shift operations that may include different shifts as standard schedule, extended hours and/or weekends.


Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients! The Senior Automation Engineer professional we seek is an individual contributor leader with these qualifications.

Doctorate degree

OR

Master's degree in Engineering & 3 years of Engineering/Automation experience in a GMP regulated industry

OR

Bachelor's degree in Engineering & 5 years of Engineering/Automation experience in a GMP regulated industry

Beyond that, additional preferred qualifications are:

  • Educational background in Electrical, Chemical and/or Mechanical Engineering
  • Extensive understanding and background in programming, design, installation and lifecycle management of manufacturing process controls, automation and field instrumentation technologies.
  • Strong process control systems automation background and experience with Tech Transfer, Process Design, and Commissioning.
  • Direct experience in process control engineering and troubleshooting with bioreactors, centrifuges, chromatography columns and systems, and/or ultrafiltration/diafiltration systems.
  • Experience with validation and change control methodology
  • Familiarity with industry standards for batch control systems, software development life cycle methodologies, 21 CFR Part 11, and GAMP. Batch processing a desired advantage.
  • Excellent written and verbal communication skills in English and Spanish
  • Ability to lead and influence multi-functional teams and embrace a team-based culture.
  • In-depth knowledge on Rockwell Automation Platform and Allen-Bradley PLCs and in programming language (e.g. VBA, SQL) and with lifecycle management of Rockwell hardware and software infrastructure.
  • In-depth knowledge of validation processes and requirements as applied to new equipment installations
  • Familiarity with OSI PI Historian.
  • Understanding of Operational Excellence and Lean Transformation in the Automation and Engineering context.
  • Ability to update and read P&IDs, instrumentation and electrical design packages including SDS, URS, IQ, OQ and VSR among other engineering and validation documentation.
  • Knowledge of ASTM 2500, ISA S88 and S95 techniques.
  • Experienced in change control, deviations, root cause analysis, identification of corrective and preventative actions, and validation practices.


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


Apply now

for a career that defies imagination

Objects in your future are closer than they appear.

Join us.careers.amgen.com

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your 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 a 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 an accommodation.

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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 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 and Puerto Rico 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.

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