Sr Engineer
Amgen
4 days ago
Remote friendly (Cambridge, MA)
United States
Other
Sr Engineer
Duties:
- Act as a drug product technical authority and provide leadership/solutions when troubleshooting oral solid drug product manufacturing across unit operations (e.g., compression, blending, milling, granulation, drying, compaction, coating).
- Lead via cross-site teams; set agenda and identify potential issues.
- Provide process development expertise for commercial drug product processing (process characterization, technology transfer, process validation, routine commercial production).
- Troubleshoot drug product processing technologies and equipment.
- Identify and manage implementation of operational improvement opportunities for current and new processes.
- Support commercial drug product manufacturing operations and contract manufacturing quality via technical evaluation of NC/CAPA.
- Visit contract manufacturing sites to support production breakthroughs and build relationships.
- Travel up to 25% (national and international unanticipated worksites). May telecommute.
Requirements:
- Master’s degree (or foreign equivalent) in Pharmaceutical Manufacturing, Pharmaceutical Science, Chemical Engineering, or related field, plus 3 years of experience in the job offered or an engineering-related occupation.
- 3 years experience applying engineering/scientific principles to wet granulation, roller compaction, blending, milling, drying, compression, encapsulation, and coating processes.
- Process characterization, technical transfer to commercial drug product sites, and process validation of oral solid drug products.
- Project management (e.g., Microsoft Project).
- Quality/regulatory systems (e.g., TrackWise, drug product manufacturing, process validation).
- Problem-solving methodologies (fishbone diagrams, 5 whys for RCA).
- Identify/evaluate critical process parameters, including statistical analysis.
Contact/Application:
- Apply via https://careers.amgen.com/en/search-jobs and search job # R-243899.
Duties:
- Act as a drug product technical authority and provide leadership/solutions when troubleshooting oral solid drug product manufacturing across unit operations (e.g., compression, blending, milling, granulation, drying, compaction, coating).
- Lead via cross-site teams; set agenda and identify potential issues.
- Provide process development expertise for commercial drug product processing (process characterization, technology transfer, process validation, routine commercial production).
- Troubleshoot drug product processing technologies and equipment.
- Identify and manage implementation of operational improvement opportunities for current and new processes.
- Support commercial drug product manufacturing operations and contract manufacturing quality via technical evaluation of NC/CAPA.
- Visit contract manufacturing sites to support production breakthroughs and build relationships.
- Travel up to 25% (national and international unanticipated worksites). May telecommute.
Requirements:
- Master’s degree (or foreign equivalent) in Pharmaceutical Manufacturing, Pharmaceutical Science, Chemical Engineering, or related field, plus 3 years of experience in the job offered or an engineering-related occupation.
- 3 years experience applying engineering/scientific principles to wet granulation, roller compaction, blending, milling, drying, compression, encapsulation, and coating processes.
- Process characterization, technical transfer to commercial drug product sites, and process validation of oral solid drug products.
- Project management (e.g., Microsoft Project).
- Quality/regulatory systems (e.g., TrackWise, drug product manufacturing, process validation).
- Problem-solving methodologies (fishbone diagrams, 5 whys for RCA).
- Identify/evaluate critical process parameters, including statistical analysis.
Contact/Application:
- Apply via https://careers.amgen.com/en/search-jobs and search job # R-243899.