Manufacturing Specialist-Process Engineer
Core
Execute manufacturing/quality systems including continuous improvement, technology transfer, process validation, and risk assessments to support biopharmaceutical production.
Role type
Manufacturing Process Engineer (Specialist)
Builds
Biopharmaceutical medicines for patients with serious illnesses
Domain
Biotechnology / Pharmaceutical Manufacturing
Required skills
process validation, technology transfer, risk assessment, troubleshooting, GMP operations, change control, process monitoring, data analysis, control charting, root cause analysis (via careerplan.io/jobs/R-250262-manufacturing-specialist-process-engineer-at-amgen)
Preferred skills
bio-processing operations, Lean principles (Kaizen, Six Sigma), cross-functional team leadership, project management, technical writing, regulatory interactions
Technologies
control charting, GMP production systems
Responsibilities
Initiate and approve manufacturing procedures; assess process performance and provide troubleshooting; implement continuous improvement initiatives; support technology transfer and new product introductions; manage non-conformance and CAPA; assist with process validation protocols; participate in regulatory inspections; assess manufacturing change control records
Seniority
Mid-level, hands-on IC
