Sr. Specialist, Engineering (Onsite)
Core
Lead operational readiness and startup for a sterile clinical drug product manufacturing facility expansion, ensuring GMP compliance and process validation.
Role type
Senior Specialist, Sterile Operations Engineering
Builds
Aseptic drug product filling, lyophilization, and formulation suites for clinical trials
Domain
Biopharmaceuticals / Clinical Supply Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP/aseptic technique, equipment qualification, process optimization, root cause analysis, technical writing, data analysis
Preferred skills
Automation, continuous improvement, process engineering
Technologies
MS Access, Excel, Minitab, Power BI, R Shiny
Responsibilities
Operate aseptic formulation and lyophilization equipment; develop SOPs and training curricula; lead operational readiness planning and risk assessments; troubleshoot complex manufacturing equipment; conduct process hazard analysis; manage project assignments for facility startup.
Seniority
Senior, hands-on IC
