The Senior Engineer reports to the Senior Manager of the Downstream Process Engineering group. Working under minimal direction, the position is responsible for providing process engineering support at the Amgen Rhode Island site. Specific duties include:
- Applying engineering principles to recommendation, design, and implementation of new equipment or system modifications
- Working closely with multiple disciplines, including manufacturing, engineering, utility operations, maintenance, quality assurance, and validation to implement operational improvements
- Provide technical support to commercial manufacturing as needed
- Troubleshoot and resolve equipment, automation or process issues in the field
- Apply LEAN methodology to ensure optimal and cost-effective performance and reliability for process systems
- Develop, organize, analyze, and present results for operational issues and engineering projects of moderate scope and complexity
- Communicating proactively with supervisor and support staff, highlighting issues and proposing solutions
Master's degree and 3 years of Engineering experience
Bachelor's degree and years of Engineering experience
Associate's degree and 10 years of Engineering experience
High school diploma / GED and 12 years of Engineering experience
- Bachelor's Degree or Master's Degree in Chemical Engineering or related technical field
- 5+ years experience in engineering in a manufacturing support environment with at least 3 years experience in the Pharmaceutical or Biotechnology industries.
- Experience with Mammalian Cell Culture, Protein Purification, Clean Utilities, CIP, SIP and Production Services. Upstream unit operation experience such as bioreactor or harvest equipment desired.
- Familiarity designing, troubleshooting, and operating equipment used in cell culture manufacturing including disposable technologies
- Experience with Tech Transfer, Process Design, and Commissioning & Qualification
- Experience with validation and change control methodology
- Direct experience with regulated environments (i.e. cGMP, OSHA, EPA) including detailed understanding of cGMPs.