Principal/Senior Principal Process Engineer, Aseptic Operations/Filling
Core
Leading product technology transfers and process validation for aseptic filling operations in pharmaceutical manufacturing.
Role type
Principal/Senior Principal Process Engineer (Aseptic Operations/Filling)
Builds
New manufacturing capabilities and technologies for drug products
Domain
Pharmaceutical manufacturing / Biologics processing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Pharmaceutical/biologics processing principles, cGMP regulations, formulation development, filling process characterization, data analysis, statistical tools, root cause analysis, gap assessment, risk assessment
Preferred skills
Mentoring junior engineers, cross-functional collaboration, regulatory inspection preparation
Technologies
None explicitly listed
Responsibilities
Lead technology transfers and process validation activities, support equipment qualification and commissioning, prepare rationale for regulatory inspections, author regulatory submissions, facilitate gap and risk assessments, mentor junior engineers
Seniority
Principal (8+ years) / Senior Principal (12+ years), hands-on IC with mentorship
