Engineer
- Employer
- Amgen
- Location
- Rhode Island, RI, US
- Start date
- Jun 12, 2019
View more
- Discipline
- Engineering, Chemical Engineer, Process Engineer, Science/R&D, Bioengineering, Biotechnology
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Best Places to Work
Job Details
As an Engineer in the Drug Substance Technology & Engineering Team, you will be responsible for the technology transfer and commercial support of biologics drug substance processes across the network, including both the Amgen manufacturing network and/or Contract Manufacturing Organizations. You will work as a member of a team of engineers and scientists, as you use engineering principles to implement manufacturing process in a cGMP environment.
Job Responsibilities include but are not limited to:
- Provide solutions to a variety of technical problems of moderate scope and complexity.
- Evaluate (under general supervision),, 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.
- Perform as a technical expert to equipment or systems regarding troubleshooting operations. Frequently become actively involved in daily operations when required to meet schedules or to resolve complex problems.
- Monitor routine manufacturing processes for performance indicators and operations. Suggest problem resolution and provide troubleshooting guidance.
- Apply engineering principles and statistical analysis, including design of experiments, in-order to solve processing issues and evaluate opportunities for process improvements
- Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for processes and/or system modifications.
- 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.
- Communicate and collaborate with technical and management staff within Manufacturing, Process Development, and Quality departments.
- Support non-standard shift organization and extended hours, as per business needs.
Basic Qualifications
Master's degree
OR
Bachelor's degree and 2 years of Engineering or Operations experience
OR
Associate's degree and 6 years of Engineering or Operations experience
OR
High school diploma / GED and 8 years of Engineering or Operations experience
Preferred Qualifications
- Education background in Chemical Engineering, Bioengineering or Biotechnoloy
- 2+ years of experience in a Process Development/Process Engineering environment, with specific experience in the implementation and support of biopharmaceutical manufacturing processes.
- Experience in process scale-up and technology transfer from laboratory to pilot and/or manufacturing scale
- Experience working with commercial manufacture of biologics using single use technology
- Basic understanding cGMP requirements
- Experience related to upstream and/or downstream biologics process development technology transfer, scale-up and ongoing manufacturing of biologics (cGMP). This includes technical support for nonconformance investigations and other commercial support activities
- Experience in working with design and optimization of pharmaceutical processing unit operations including cell expansion, harvest, clarification, Protein A, IEX, SEC, TFF, UFDF, and sterile filtration among others for a variety of biological molecules
- Experience in the analysis of data generated from a variety of analytical techniques
- Regulatory knowledge and interactions
- Project management skills
- Strong oral and verbal communication and presentation skills
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.
Company
We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.
We live the mission.
We win together.
We thrive on continual challenge.
Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.
At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.
Connect with us to explore how you can Win, Live, and Thrive at Amgen.
- Website
- http://careers.amgen.com/
- Phone
- 805-447-1000
- Location
-
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States
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