Senior Microbiologist

Location field must contain 'city, state' or a zip code to perform a radius search (e.g., Denver, CO or 46122 ). City and state must be separated by a comma followed by a space (e.g., Houston, TX )
Haemonetics Corporation Senior Microbiologist Seattle , Washington Apply Now
We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further - Haemonetics is your employer of choice.Job DetailsPURPOSEThe Senior Microbiologist is responsible for the sterility evaluation of medical device (MD) products and combination products for safety per ISO standards and applicable regulations. The role is responsible for assisting in the design and implementation of test systems and procedures for the governance of sterility testing. The Senior Microbiologist will apply subject matter expertise to solve complex problems, utilizing technical acumen, business experience and independent judgment. This role is responsible for developing sterilization evaluation plans and reports for disposable medical device products.The Senior Microbiologist will function as a key team member collaborating with associates from diverse technical backgrounds. They must efficiently execute sterility evaluations, testing, and reporting for product development and product life cycle management. This person will provide experience and knowledge of product safety data and procedures to support on-site and off-site Regulatory Authority audits to support product, which may be sold in various worldwide markets.RESPONSIBILITIESDevelops sterilization strategies for disposable blood devices, implementing a tiered risk-based approach to establish regulatory compliance in support of new product development and registration for sterility studies.Plans and manages sterilization plans, testing and/or rationales based on changes in manufacturing, supplier information, material, etc changes to medical devices.Review, interpret, and summarize raw data from Contract Research Organization reports and documents biological assessments using sound scientific principles.Ensure that testing meets all international & domestic test requirements according to ISO, FDA, EU MDR, and GLP.The Microbiologist will be responsible for ensuring effective sterilization processes and compliance to all related standards for all Haemonetics products.This position will be responsible for execution of technical strategy including writing of protocols and reports, collaboration with external sterilization resources and direct interaction with all Haemonetics manufacturing plants.Timely disposition of any sterilization and environmental monitoring issues that could impact Haemonetics supply chain is a priority for this role.The ideal candidate should have experience in working with EtO, Gamma, Ebeam and steam sterilization processes with full understanding of all related international standards.Preferred experience with the following standards: ANSI/AAMI ST72, ISO 11135, ISO 11737, ASTM E3251, ASTM E3244, ISO15747, ISO11607 and European Pharmacopeia.Interact closely with and provide consultative direction to Quality, R&D, Clinical, and Regulatory Affairs within Haemonetics.Support on-site and off-site Regulatory Authority audits to for product that may be sold in worldwide markets.REQUIRED KNOWLEDGE, SKILLS AND ABILITIESFunctional expert in the sterilization principles of disposable medical devices.Knowledge of applicable ASTM, ISO, FDA, and EN standards with an in-depth understanding of sterility standards for blood disposable products.Ability to work independently to develop, execute and document sterilization studies.Proficient in Microsoft suite of applications.Exhibits pro-active behavior and organizes meetings to maintain high product quality standards for all medical devices.Proficient with statistics.Effectively balances multiple priorities and project deliverables.Ability to accurately scope projects and consider the full impact of decisions and actions taken.Ability to establish and maintain effective working relationship