Senior Engineer

The Senior Engineer works as part of a multi-disciplinary program team to build drug delivery solutions which meet user requirements for portfolio of therapeutic products from concept through commercial entry. The individual advances technical programs, contributing to definition of design requirements, identification and realization of technical solutions, authoring of test methods and reports, and authoring of technical analyses to advance programs. The successful candidate establishes well-supported insights for development, clinical and commercial stage solutions to serve user needs and the needs of the pipeline portfolio, using a range of program tools, design characterization and verification methods, and design reviews. Ensures that the required performance and quality targets are satisfied and helps identify and reduce technical risks on the program.Responsibilities include but are not limited **a) support/ lead process development and commercialization of gas sterilization processes of combination productsb) coordinate/ lead manufacturing site requirements to support sterilization requirementsc) support the design control process and qualification of primary componentsd) support/ lead tech transfer projects for combination productse) support/ lead the development and operational improvements with key primary component suppliersg) support development of characterization methods for mechanical and physical properties of primary componentsh) support on-going deviation/ CAPA and change controli) support/ lead supplier/ raw materials sterility assurance assessmentsj) collaborate extensively with internal and external stakeholders i.e. manufacturing, suppliers, quality, regulatory, senior management, etc.k) drive and influence key opinion leaders by providing technical papers, presentations and attending key conferences** Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experienceSterilization experienceQualification/ quality experienceCommercial process lifecycle management

Created: 2025-02-22