Senior Microbiologist

Senior Microbiologist (12-Month Contract)Hybrid | Medical DeviceCandidates must be authorized to work in the U.S. without current or future visa sponsorship. We are unable to support corp-to-corp (C2C) arrangements for this position.About the RoleOur client, a global medical device manufacturer, is looking for a Senior Microbiologist to act as a technical expert across outsourced manufacturing, new product programs, and business integration efforts. This person will be the go-to resource for microbiological risk, working with Quality, Manufacturing, Supplier Quality, R&D, Regulatory, and external manufacturing partners to keep products safe, compliant, and on schedule.The role suits a scientist who is comfortable influencing decisions through sound technical reasoning and enjoys working across functions and sites.What You’ll DoProvide microbiology expertise for products built by external manufacturing partnersContribute to due diligence, integration, and site or product transfer projects tied to business acquisitionsConduct microbiological risk assessments covering materials, processes, facilities, products, and supplier changesWrite and review microbiology evaluations, technical justifications, and related scientific documentationDetermine the microbiological impact of design, process, material, supplier, and facility changesSupport nonconformances, investigations, and CAPAs that require microbiology inputAdvise development teams on microbiological considerations through design, launch, and lifecycle managementTake part in audits, regulatory inspections, and inspection readiness effortsDrive improvements to microbiology-related quality processesClearly present risks, recommendations, and supporting rationale to stakeholders in multiple regionsWhat You BringBachelor’s degree in Microbiology, Biology, Biomedical Science, or a related field5+ years of experience in microbiology, quality, manufacturing, or engineering within a regulated environmentTrack record of technical risk assessments and scientific evaluationsStrong technical writing abilityAbility to run several projects at once with minimal oversightClear communicator who can manage a wide range of stakeholdersNice to HaveMedical device background (highly preferred)Experience overseeing outsourced or contract manufactured productsExposure to acquisitions, tech transfers, or product transfersWorking knowledge of bioburden, environmental monitoring, contamination control, and sterilizationHands-on CAPA, investigation, and change control experienceFamiliarity with FDA requirements, ISO 13485, and global quality standardsExperience on global, cross-functional teams and presenting to leadershipTravelRoughly 10-20% travel to support sites, audits, transfers, and project needs.