Summary: Senior Microbiologist will mainly in charge for the sterilization program, maintain environmental monitoring program, conduct investigations, work with quality regulations and guidelines, assess necessary lab adjustments, perform risk assessments, and ensure compliance to sterilization and microbiology testing standard.
Essential Duties and Responsibilities: Maintains regulatory compliance of the sterilization program for sterile implantable devices by performing process re-qualifications, new product qualifications, and risk assessments.Coordinates microbiological testing, release of product and testing for validation protocols.Reads and interprets microbiological cultures and other related tests including but not limited to environmental monitoring, sterility tests, growth promotion, microbial limits tests and antimicrobial effectiveness tests. Supports environmental particulate and microbial testing for ISO certified cleanrooms, Heating Ventilation & Air Conditioning (HVAC) systems, Compressed Air Gas Systems, and Pharmaceutical Grade Water Systems.Supports laboratory testing including, but not limited to, bacterial gram staining, growth promotion, microbial identification, bacterial endotoxin testing, bioburden recovery, and sterility testing.Supports all tasks related to laboratory upkeeping and the environmental monitoring program.Coordinates testing with contract laboratories (scheduling, submitting samples, reviewing results, conducting investigations, creating and maintaining Purchase Orders) Assesses changes to cleanroom environments by supporting the Equipment Transfer Plan program.Coordinates and supports facility, equipment, and HVAC maintenance events between multiple departments.Performs risk assessments for deviations, OOS events, CAPAs, NCMRs, and COPs.Creates Experimental Requests to support special studies and projects.Develops, generates, and supports Performance Qualification and Validation protocols and reports.Develops test method validations in support of microbiology operations.Performs risk assessments for changes related to manufacturing process changes, product development, material biocompatibility, and product changes. Develops equipment, product, and process cleaning and disinfection validations.Ensures regulatory compliance of product and material biocompatibility by performing safety assessments and testing for sterile implantable medical devices to support existing product and/or process changes and new products.May perform validation, technology transfer and troubleshooting, and write policy procedure for quality initiatives. Reviews and approves environmental monitoring data and laboratory equipment and records.Prepares process and status reports, assigns and monitors document numbers and reviews documents for accuracy and completeness.May performs supplier audits to assess changes impacting sterilization and biocompatibility.Works and communicates effectively and professionally with others inside and outside the company.Maintains regulatory compliance of the environmental monitoring program for the Heating Ventilation & Air Conditioning (HVAC) systems, Compressed Air and Gas Systems, and Pharmaceutical Grade Water Systems.Leads the team to properly execute and complete daily tasks per schedule under the guidelines of established Procedures. Required Qualifications: Microbiology, Biology, or equivalent Bachelor's degree.Experience in sterilization field (i.e. validation, risk assessment, new product adoption)Experience in monitoring of environmental systems (i.e. HVAC, Cleanroom, Compressed Air, Compressed Gases, Water).Able to communicate effectively and computer literate. Preferred Qualifications: (Optional) 5+ years industry experience in medical, biopharmaceutical or pharmaceutical or similar environment.Knowledge of the following standards and regulations: 21 CFR 820, ISO 13485, CMDR, and EEC93/42, US and EU Pharmacopeia , , AAMI/TIR 30, AAMI/TIR 52, International Organization for Standardization (ISO) 10993, 14644, 11137, 11737, 14971, and other risk guidance standards.Experience in maintaining, supporting, and developing test methods for sterilization of medical devices and biocompatibility testing. Experience with pro-longed contact and permanent implantable devices Experience and Education Requirements: Bachelor's degree and minimum 5 years of related experience; or 3 years and a Master's degree; or a PhD without experience; or equivalent combination of education and experience. Medical Device experience preferred. Travel Required (select one, delete others): Up to 25%