Senior Engineer, CS&E Process Development

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.

Sr. Engineer

Live

What you will do

Lets do this. Lets change the world. In this vital role as a Sr Engineer in the Process Development Drug Substance Cell Sciences & Engineering team you will independently provide and/or direct the characterization of process optimization strategies and/or troubleshooting of operational issues in the manufacturing of routine commercial products and/or associated capital projects related to equipment and/or technology transfers. You will be responsible to support the execution of manufacturing/quality systems such as deviations, process validation, process monitoring, and new product introductions. You will work with a team of Scientists and Engineers by applying advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, process changes and/or capital projects.

• Complete complex or novel assignments requiring development of new and/or improved engineering techniques and procedures.
• Coordinate and review work of a small group of engineer staff, associates and/or technicians on an ongoing basis as well as on a project basis.
• Employ advanced engineering techniques and/or modifications of advanced techniques within area of engineering expertise.
• Apply knowledge of engineering principles and practices outside of area of discipline expertise to broad variety of assignments in related fields.
• Application of mature engineering knowledge in planning and conducting projects.
• Prompt and regular attendance to workplace.
• Provide solutions to a large variety of technical problems of moderate to large complexity using ingenuity and creativity. Frequently become actively involved in daily operations when required to meet schedules or to resolve complex problems.
• Work with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing requirements and recommendations for processes and/or highly complex system modifications.
• Routinely monitor manufacturing processes for performance indicators and operations. Suggest problem resolution and provide troubleshooting guidance.
• Work with project managers to complete design and engineering projects within schedule, budget and quality constraints.
• Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.
• Support non-standard shift organization and extended hours, as per business needs

Win

What we expect of you

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

Basic Qualifications:

Doctorate degree in Engineering

OR

Masters degree in Engineering & 3 years of experience of Process Development and/or Technical Service support in GMP regulated industry

OR

Bachelors degree in Engineering & 5 years of experience of Process Development and/or Technical Service support in GMP regulated industry

Beyond that, additional preferred qualifications are:

• Educational background in, Chemical, and/or Biomedical Engineering.
• Experience working with the commercial manufacture of biologics
• Detailed technical understanding of bio-processing unit operations for cell culture and harvest processes
• Experience in process scale-up and technology transfer from laboratory to pilot and/or manufacturing scale
• Experience in working with design and optimization of pharmaceutical processing unit operations including cell expansion, harvest and clarification
• Experience in the analysis of data generated from a variety of analytical techniques
• Familiarity with validation and documentation processes in a highly regulated environment.
• Ability to interpret and apply GLPs and GMPs.
• Ability to apply engineering science to production.
• Interacts effectively with variety of communication and working styles.
• Ability to handle multiple projects at one time
• Skills in the development of hypotheses and approach.
• Skills in the following areas:
• Problem solving and applied engineering.
• Basic technical report writing
• Fully bilingual (Spanish and English)
• Technical presentations
• Personal Organization
• Validation Protocol Writing
• Dealing with and managing change
• Analytical Problem Solving
• Computer Literacy
• Negotiation, persuasion and facilitation
• Project cost development
• Conflict resolution
• Leadership and team building
• Schedule and resources loading development
• Flexibility to work extended hours

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 Plancomprising health, finance and wealth, work/life balance, and career benefitswith 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.

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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.

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.