Microbiologist

Title: Microbiologist-Sterilization Location: North Haven, CT. 06473 Duration: 12 months (with possibility of extension) Top 3 skills/experience are as follows: 1. Understanding of different types of sterilization methods (EtO, steam, etc.) including processes and equipment. 2. Knowledge in the application of international and national standards such as USP, AAMI/ANSI standards, ISO 17665 (Steam), 11135 (EtO), ISO 11737 (Microbial Method), ISO 14644 (Controlled Environments), ANSI/AAMI ST72 and others as applicable (i.e. EN). 3. Ability to complete accurate and effective technical writing deliverables/reports. We would prefer someone local who can sit on site at the North Haven, CT location. We plan to hire a Mid-senior level and a Mid-level candidate. Responsibilities may include the following and other duties may be assigned: Review and interpret FDA, EU and other international regulations, standards and guidelines covering sterilization and microbial contamination control in the manufacture of sterile medical devices Complete studies needed to address compliance requirements for medical device microbial control and sterility Create and/or update technical documentation, programs, and processes as needed to align with EU MDR and international regulation and standard guidance Collaborate with internal and external crossfunctional teams to ensure successful implementation of program/process changes needed to meet regulations Train and adhere to quality system procedures applicable to products in scope of responsibilities Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience. Preferred Qualifications: Familiarity with FDA, EU and other international regulations, standards and guidelines covering sterilization and microbial contamination control in the manufacture of sterile medical devices. Understanding of different types of sterilization methods (EtO, radiation, steam, etc.) including processes and equipment Knowledge in the application of international and national standards such as USP, AAMI/ANSI standards, ISO 17665 (Steam), 14160 (Liquid), 11137 (Radiation), 11135 (EtO), ISO 11737 (Microbial Method, ISO 10993 (Biocompatibility), ISO 14644 (Controlled Environments), ANSI/AAMI ST72 and others as applicable (i.e. EN). Proven collaborator and team player. Excellent organizational and judgment skills. Ability to maintain and generate accurate records. Strong written and verbal communication skills