Our client, a Global Leader in the Medical Device Industry has an immediate opening for a Microbiologist for a 12 month + Contract. Our client offers results-driven people a place where they can make a difference - every day! You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment.
Position Description (Principle Duties and Responsibilities)
Identify, isolate and study microorganisms and their byproducts as it relates to the sterilization of medical devices. Maximize the biocompatibility of products using industry guidelines and advanced testing technologies. Work closely with operations groups to lead continuous quality improvement initiatives. Coordinate and complete projects with minimal supervision.
Apply cGLP, cGMP, ANSI, AAMI, ISO, FDA, EPA, and USP guidelines to the bioburden, cytotoxicity, bacterial endotoxin, and biocompatibility analysis of medical devices.
Lead and participate in the development and improvement of the manufacturing processes for existing and new products.
Lead in the development, review and approval of sterilization process and equipment validation/qualifications (IQ, OQ & PQ).
Be the subject matter expert and point of contact for suppliers for new process development, quality issues and process improvements for assigned projects.
Support product transfers.
Review/approve product and process change control documentation and specifications.
Review/approve nonconforming material and system documentation.
Act as mentor to others.
Bachelors degree required, focus in Microbiology, Biology, or Chemistry preferred.
1+ years of applied device or pharmaceutical microbiological or biological testing, research and development, or sterility assurance experience.
Demonstrated knowledge of a variety of microbiological concepts, practices, and procedures.
Demonstrated knowledge of the fundamentals of ethylene oxide sterilization.
Demonstrated ability to maximize the biocompatibility of products using industry guidelines and advanced testing technologies.
Ability to complete complex tasks using creativity, personal experience and good judgment.
Ability to apply ISO, AAMI, USP, ANSI, EPA, EU and related guidelines toward the design, manufacturing, development, and launch of innovations that are strategically important to the business.
Demonstrated ability to solve problems, troubleshooting, and organize priorities.
Demonstrated interpersonal communication skills.
A positive, energetic team player, and an advocate for product excellence and quality.
Must be results oriented, a quick learner, and able to respond to the urgent needs of the team ensuring all deadlines are met.