Senior Engineer

Amgen is one of the world’s leading biotechnology companies. Amgen is a values-based company, deeply rooted in science and innovation to transform new ideas and discoveries into medicines for patients with serious illnesses.

FUNCTIONS General: - Complete complex or novel assignments requiring development of new and/or improved engineering techniques and procedures. 2. Develop engineering policies and procedures that affect multiple organizational units. 3. Supervise, coordinate and review work of a small staff of engineers, associates and/or technicians on an ongoing basis as well as on a project basis. 4. Employ advanced engineering techniques and/or modifications of advanced techniques within area of engineering expertise. 5. Apply knowledge of engineering principles and practices outside of area of discipline expertise to broad variety of assignments in related fields. 6. Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area. 7. Application of mature engineering knowledge in planning and conducting projects. 8. Prompt and regular attendance to workplace Manufacturing Operation Support: - Support Root Cause Analysis (RCA) for nonconformance (NC) investigations. 2. Develop Product Impact Assessment (PIA) related to Non Conformances (NC) in the manufacturing process 3. Write documentation to support NC investigations. 4. Own and support implementation of CAPAs to reduce incidence of nonconformance (NC) events related to particles in solution, yield events, low fills, etc. Tasks include, and are not limited to: a. Develop, present, negotiate and get approval for CAPA proposals b. Execute Test Runs in the manufacturing area and laboratories c. Perform analysis of data, using statistical tools whenever applicable d. Write technical documents (requiring robust scientific and technical knowledge) 5. Develop and execute process characterization to define process that will be then implemented via Change Control process 6. Lead execution of improvement projects to make manufacturing operation more effective and efficient. Be able to lead teams and apply Project Management tools and techniques.

Basic Qualifications - Bachelor's degree in Chemical,Industrial,Electric or Mechanical Engineering & 5 years of manufacturing experience OR - Master's degree in Chemical,Industrial,Electric or Mechanical Engineering & 3 years of manufacturing experienceexperience OR - Doctorate degree in Chemical,Industrial,Electric or Mechanical Engineering Preferred Qualifications o Working knowledge of pharmaceutical/biotech processes - Familiarity with validation processes - Familiarity with GMP documentation in a highly regulated environment - Ability to operate specialized laboratory equipment and computers as appropriate. - Ability to interpret and apply GLPs and GMPs. - Ability to apply engineering science to production. - Able to develop solutions to routine technical problems of limited scope - Demonstrated skills in the following areas: - Problem solving and applied engineering. - Basic Complex technical report writing - Verbal communication - Business writing - Comprehensive understanding of validation protocol execution requirements. - Demonstrated Skills in the following areas: - Basic technical presentations - Personal Organization - Validation Protocol Writing - Dealing with and managing change - Technical (Equipment Specific) - Analytical Problem Solving - Computer Literacy - Statistics - Specialized equipment/process expertise - In-depth knowledge of validation manufacturing technical processes and requirements as applied to new equipment installations - Interacts effectively with variety of communication and working styles - Ability to independently determine when additional internal resources are required to solve problems - Ability to handle multiple projects at one time - Demonstrated Skills in the following areas: - Schedule development - Facilitation - Collaboration - Basic project management - Completion and follow-up - Statistics - Established expertise in at least 3 separate areas of engineering technology. - Ability to independently determine when additional external resources are required to solve problems - Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope - Problem solving skills requiring the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach - Working knowledge of financial analysis tools - Ability to delegate and manage the project work of others - Demonstrated Skills in the following areas: - Negotiation, persuasion and facilitationCollaboration - Project cost development - Conflict Resolution - Leadership and teambuilding - Technical writing - Business communication - Management of contractors and vendors