Engineer III/Sr. Engineer I, Manufacturing Sciences – Drug Product
Core
Provide scientific and technical expertise to support aseptic drug product manufacturing, including formulation, sterile filtration, aseptic filling, and process validation.
Role type
Manufacturing Sciences Engineer (Drug Product)
Builds
Sterile biopharmaceutical products
Domain
Biopharmaceutical manufacturing (aseptic/sterile)
Required skills
Aseptic filling, sterile filtration, formulation, GMP requirements, aseptic manufacturing principles, process validation, root cause analysis, CAPAs, data analysis
Preferred skills
Process validation, aseptic process simulations, leading complex technical projects, risk-based technical assessments, regulatory documentation, acting as technical SME
Responsibilities
Design and execute laboratory and manufacturing support studies, lead drug product technology transfers, perform root cause analyses and implement CAPAs, support process validation activities (media fills, PPQ), analyze manufacturing data and communicate technical conclusions
Seniority
Mid-level (2-4 years experience)