Senior Engineer I/II, Manufacturing Sciences – Drug Product
Core
Senior Engineer supporting aseptic drug product manufacturing, providing technical expertise in sterile filling, filtration, and process validation to ensure reliable commercial operations.
Role type
Senior IC manufacturing scientist (pharmaceutical)
Builds
sterile biopharmaceutical products
Domain
Biopharmaceutical manufacturing / Aseptic processing
Required skills
aseptic filling, sterile filtration, GMP compliance, process validation, root cause analysis, CAPA implementation, experimental design, data analysis
Preferred skills
aseptic process simulations, leading complex technical projects, risk-based assessments, regulatory documentation, technical SME leadership
Technologies
aseptic filling equipment, sterile filtration systems, media fill systems, validation software
Responsibilities
Design and execute laboratory and manufacturing support studies to improve process robustness; Lead or support drug product technology transfers into GMP manufacturing; Perform root cause analyses and implement CAPAs for manufacturing investigations; Support process validation activities including media fills and PPQ campaigns; Analyze manufacturing data and communicate technical conclusions to stakeholders.
Seniority
Senior, hands-on IC