Microbiologist

*** As a Microbiologist you will apply cGLP, cGMP, ANSI, AAMI, ISO, EUMDR, FDA and USP guidelines to the bioburden, cytotoxicity, bacterial endotoxin, and biocompatibility analysis of orthopaedic implants and surgical instruments for Stryker s Leesburg, VA facility.
" Actively support new product validation activities.
" Participate in the development and improvement of the manufacturing processes for existing and new products.
" May lead in the development, review and approval of sterilization process and equipment validation/qualifications (IQ, OQ & PQ).
" Be the point of contact for suppliers for new process development, quality issues and process improvements for assigned projects.
" Assist in Tech Doc preparation and updates.
" Assist with Notified Body responses - research to find the how, why and what is needed to meet EUMDR requirements
" Assist with impact assessment reviews prior to launch/implementation.
" Assess various ISO Standard revisions and the associated impact to existing process/procedures.
Qualifications:
" Bachelor s Degree in Biology, Microbiology, or a closely related life science.
" 5 years of applied device or pharmaceutical microbiological or biological testing, research and development, or sterility assurance experience.
" Must understand the fundamentals of one of the following sterilization techniques: gamma irradiation, ethylene oxide.
" Prefer demonstrated competency in advanced testing technologies.
" Prefer demonstrated knowledge of statistics.
" Demonstrated knowledge about a variety of microbiological concepts, practices, and procedures.
" Ability to use ISO, AAMI, USP, ANSI, EUMDR and related guidelines toward the design, manufacturing, development, and launch of initiatives.
" Ability to effectively work cross-functionally with Product Development, Operations and Marketing.
" Demonstrated ability to manage workload.
" Demonstrated communication skills across different organizational levels.
" Must be results oriented, a quick learner, team player and able to respond to the urgent needs of the team ensuring all deadlines are met.
" Demonstrated ability to technically mentor associate engineers and scientists.