Senior Engineer – MSAT (NPI)
Core
Define operational/technical standards for medical device manufacturing sites and drive implementation of improvements to maximize throughput and capacity utilization.
Role type
Senior IC manufacturing engineering lead (NPI)
Builds
GMP manufacturing processes, scale-up, and technology transfer for biopharmaceutical products/devices
Domain
Biopharmaceuticals / Medical Devices / Manufacturing Engineering
Required skills
Process development, scale-up, technology transfer, GMP compliance, equipment design, troubleshooting, project management, technical documentation, statistical data analysis, regulatory submissions
Preferred skills
Chemical or Life Sciences background, FDA/ISO regulated industry experience
Technologies
GMP systems, URS/FS/DDS documentation, statistical analysis tools
Responsibilities
Lead troubleshooting of operations and develop preventative maintenance procedures; Establish equipment specifications in standard documentation (URS, FS, DDS); Coordinate work of consultants and engineering firms on design documents; Drive key equipment, systems, and facility improvement projects; Provide technical support and analysis for resolution of deviations and process issues; Author technical reports, technology transfer packages, and presentations.
Seniority
Senior, hands-on IC with mentorship responsibilities