Engineer III, Manufacturing Sciences
Core
Technical contributor for end-to-end single-use consumable raw materials in biopharmaceutical manufacturing, supporting process optimization, regulatory compliance, and extractables/leachables assessments.
Role type
Manufacturing Sciences Engineer (IC)
Builds
Single-use consumable raw materials, control strategies, and regulatory documentation for Drug Substance through Drug Product fill.
Domain
Biopharmaceutical manufacturing / Materials science
Required skills
polymeric materials knowledge, chemistry expertise, single-use systems experience, deviation/CAPA/regulatory documentation handling, root cause analysis, risk assessment
Preferred skills
extractables and leachables studies, container closure systems, supplier change management, manufacturing organization experience, external vendor partnership
Technologies
single-use systems, container closure systems
Responsibilities
Serve as technical POC for single-use consumable raw materials and supplier capabilities; Lead continuous improvement initiatives for raw materials; Conduct investigations via laboratory experiments and data analysis; Troubleshoot single-use material failures and perform root cause analyses; Perform technical risk assessments for Vendor Change Notifications and New Item Requests; Own and support global extractables/leachables studies; Support internal and agency inspections and vendor audits.
Seniority
Mid-level IC (2+ years experience)