Senior Principal Engineer, Sterile Fill
Core
Global subject matter expert for the design, technology selection, commissioning, qualification, and lifecycle support of aseptic manufacturing equipment across pharmaceutical and biologics facilities.
Role type
Senior Principal Engineer, Sterile Fill
Builds
Aseptic filling lines, isolators, barrier systems, sterilization systems, and supporting equipment for global capital projects and operational sites.
Domain
Pharmaceutical manufacturing / Biologics / Sterile processing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Aseptic manufacturing equipment expertise, EU GMP Annex 1 compliance, Contamination Control Strategies (CCS), Vendor technical assessments, FAT/SAT/IQ/OQ/PQ documentation review, Root cause investigation, CAPA development, Global engineering standards development, Project leadership from concept to qualification
Preferred skills
Master's degree in Engineering, Experience with industry leaders (B&S, Syntegron, Groninger, Optima, Skan, EMA), Managing global equipment vendors, Mentoring next generation of leaders
Technologies
Vial filling lines, Syringe filling lines, Cartridge filling lines, Isolators, Lyophilizers, Autoclaves, Depyrogenation tunnels, CIP/SIP systems
Responsibilities
Serve as global subject matter expert for aseptic manufacturing equipment and sterile processing technologies; Support global capital projects and manufacturing sites with expert guidance on aseptic processing technologies; Establish and maintain engineering standards and best practices for sterile manufacturing equipment; Support implementation of Contamination Control Strategies (CCS) across sterile manufacturing facilities; Lead technical evaluations and technology selection for aseptic manufacturing systems; Provide technical oversight during equipment design, procurement, and integration; Provide expert troubleshooting support for complex aseptic equipment and sterile manufacturing systems; Lead root cause investigations related to equipment performance issues, sterility risks, and contamination events.
Seniority
Senior, hands-on IC with strategic project leadership
