Senior staff microbiologist

Work Flexibility: Hybridpb​Senior Staff Microbiologist - Hybrid /b /pp**12 month fixed term contract** /ppbNot lab based /b /ppbPosition requirements /b /ppThe Senior Staff Microbiologist will be primarily responsible for providing technical input into the sterility compliance of Stryker's product in accordance with relevant regulatory requirements and standards for medical devices, at a muti site / global level. The staff microbiologist will oversee and act as subject matter expert / technical lead in all areas of microbiology and ensuring sustained levels of sterility compliance. /pppbPosition Requirements /b /p /ppWill work within the microbiology team, with responsibility to ensure effective and efficient sterility practices, which includes, but not limited to the following: /pliOversight of environmental utility monitoring, bioburden and endotoxin testing practices and procedures, creating alignment and standardization across multi sites. /liliExecution, review and approval of Gamma and Ethylene Oxide sterilization validations and re-qualifications in line with relevant BS EN ISO standards. Assessment of sterility supplier validation. /liliInterpreting sampling and monitoring data, applying statistical and analysis techniques, to determine control and trending. Indentifies and initiates when to take action. /liliLead technical input to NC and CAPA resolution within the Microbiology group and across multiple business units / sites. Strong competency in in assessment of effectivity and resulting sterility compliance. Review and approval of CAPA. /liliAct as technical lead for microbiology in cross functional groups including product and process issues, rootcausing, projects, initiatives and other business critical forums.. /liliSubject Matter Expert, audit and review of Supplier quality activities with critical vendors in area of microbiology. /liliReview and approval of sterilisation validations and re-qualifications in line with relevant BS EN ISO standards. Assessment of sterility supplier validation. /liliContinually identifies opportunity for stabilization of trends, statistical control of processes to allow cost saving. /liliMentors and trains team and cross functional groups as required (induction, GMP etc) /liliSubject matter expert to internal external regulatory requirements, (including but not limited to European RHQ, Division, Corporate, FDA, ISO, MDD, and individual country regulatory requirements) /liliSubject matter expert to multi-siye / global procedures, contribute to the development, maintenance and improvements of the policies and procedures to align to best practices, benchmarking against industry leads and regulatory requirements. Input / BPO to corporate documents. /liliCoach, mentor and train other functions in area of sterility and monitoring. /liliSupport of, ensure compliance of new products to sites’ sterility standards. Ensure successful integration of products into validated processes. /liliOversight approval of biocompatible assessments of components, materials and consumables used in the manufacture of Stryker product. /liliProvides Technical Assessment for completion of Risk Assessment for SofHA in area of sterility and microbiology. Assessment and approval of acceptance of resolution to quality issues including concession management. /liliDemonstrate technical supervisory capabilities and leads projects to completion. /lippbQualification Knowledge Skills /b /p /pliBachelor degree Microbiology or equivalent/ related subject required, with 6 years Microbiology related experience /lilipMinimum of 8 years in Quality/Regulatory Affairs environment. /p /lilipExperience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) required. /p /liliLead auditor certification desirable. /liliThorough knowledge and understanding of US and International Medical Device Regulations and standards in area of expertise (Microbiology) /liliMust possess strong communication, project management and influencing skills as well as have the ability to manage multiple tasks simultaneously. /liliKnowledge of trends in industry and reg standards. /liliCompetent in presenting problems and their solutions. /liliGood financial acumen. /liliStrong Project management. /liliExperience in leadership/management of people. /liliStrong interpersonal skills. /liliStrong written and oral communication and negotiations skills. /liliStrong in critical thinking and "outside the box" thinking. /liliHighly developed problem solving skills. /liliStrong analytical skills. /liliDemonstrated ability to successfully manage and complete projects in a matrix organization. /liliDemonstrated ability to work independently. /liliExperience in working in a compliance risk situation. /liliHigh proficiency in statistal techniques, data review and analysis. /liliHigh level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages /liliSome travel may be required.​ /lilip#IJ /p /liTravel Percentage: 10%