Aseptic Manufacturing Lead
Core
Provide specialized oversight of formulation, sterile filling, aseptic processing, and associated manufacturing systems to ensure facility designs, equipment selections, and operational strategies support aseptic manufacturing requirements, contamination control objectives, regulatory expectations, and startup readiness.
Role type
Senior IC aseptic manufacturing engineering lead
Builds
Drug product manufacturing and fill-finish operations for pharmaceutical and biotechnology clients
Domain
Pharmaceutical manufacturing / Biotechnology / GMP-regulated facilities
Required skills
Aseptic processing, sterile filling, formulation, contamination control, engineering design, constructability, operability, maintainability, code compliance, multidisciplinary engineering coordination, capital project management
Preferred skills
GMP-regulated facility support, Owner's Representative or PMC experience, commissioning and qualification, startup activities, Professional Engineer (PE) license
Technologies
Engineering design tools, manufacturing systems, project management software
Responsibilities
Ensure facility designs and equipment selections meet aseptic manufacturing and contamination control objectives; Serve as primary engineering advisor for drug product manufacturing and fill-finish operations; Oversee design and engineering teams for project requirements including design reviews; Coordinate multidisciplinary engineering activities for capital projects
Seniority
Senior, hands-on IC