Engineer

Role Summary

Engineer responsible for technology transfer and commercial support of biologics drug substance processes across the Amgen network and contract manufacturing organizations. Works as part of a team of engineers and scientists to apply engineering principles in a cGMP manufacturing environment.

Responsibilities

• Provide solutions to a variety of technical problems of moderate scope and complexity to enable Technology Transfer of various clinical and commercial molecules.
• Under general supervision will evaluate, 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 associated with Technology Transfer.
• Routinely monitor manufacturing processes for performance indicators and operations. Suggest problem resolution and provide troubleshooting mentorship.
• Apply engineering principles and statistical analysis, including design of experiments, in-order to address 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.
• 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.
• Up to 15% travel is possible - domestic and international

Qualifications

• Required:
• High school diploma / GED and 8 years of Engineering or Operations experience OR
• Associate’s degree and 6 years of Engineering or Operations experience OR
• Bachelor’s degree and 2 years of Engineering or Operations experience OR
• Master’s degree
• Preferred:
• Education background in Chemical Engineering, Bioengineering or Biotechnology
• 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 manufacturer 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, MMA, CEX, Viral Filtration, UFDF, and sterile filtration among others for a variety of biological molecules. Experience working with data and digital tools preferred.
• Proficient re: the analysis of data generated from an array of analytical techniques
• Regulatory knowledge and interactions and project management skills
• Strong oral and verbal communication and presentation skills
• Fluency in foreign languages preferred

Education

• High school diploma / GED with 8 years of Engineering or Operations experience
• Associate’s degree with 6 years of Engineering or Operations experience
• Bachelor’s degree with 2 years of Engineering or Operations experience
• Master’s degree