Engineer

Role Summary

Engineer I — provide process engineering support at the Amgen Rhode Island site, reporting to the Senior Manager of the Downstream Process Engineering group.

Responsibilities

• Ensures the logical, detailed translation of design requirements and constraints into process equipment/system solutions. Assists with project definition by performing engineering studies and assessments for process equipment systems, clean utilities, and production facility improvements
• Provide technical support to commercial manufacturing as required
• Work closely with multiple teams, including manufacturing, engineering, utility operations, maintenance, quality assurance, and validation to implement operational improvements
• 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 small scope and complexity
• Apply engineering principles to recommendation, design, and implementation of new equipment or system modifications
• Communicate proactively with supervisor and support staff, highlighting issues and proposing solutions
• Ability to provide On-Call support coverage on weekends, on a rotating basis

Qualifications

• Basic Qualifications: High school diploma / GED and 8 years of Engineering or Biotechnology experience OR Associate’s degree and 6 years of Engineering or Biotechnology experience OR Bachelor’s degree and 2 years of Engineering or Biotechnology experience OR Master’s degree
• Preferred Qualifications: Bachelor’s Degree or Master’s Degree in Chemical Engineering or related technical field
• 2+ years experience in engineering in a manufacturing support environment with at least 1 year experience in the Pharmaceutical or Biotechnology industries
• Downstream unit operation experience such as Chromatography or Tangential Flow Filtration desired
• Familiarity designing, fixing, and operating equipment used in protein purification including disposable technologies
• Experience with Tech Transfer, Process Design, and Commissioning & Qualification
• Direct experience with regulated environments (i.e. cGMP, OSHA, EPA) including detailed understanding of cGMPs
• Excellent written and verbal communication skills and the ability to work with minimum direction
• Ability to apply analytical skills to evaluate and interpret problems using multiple sources of information
• Demonstrated ability to work in cross-functional teams and embrace a team-based culture
• Familiarity with designing and operating equipment used in biopharmaceutical manufacturing