Senior staff microbiologist

Ph3Senior Staff Microbiologist - Hybrid /h3 /brpb12 month fixed term contract /b /p /brpbNot lab based /b /p /brpbPosition requirements /b /p /brpThe 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. /p /brh3Position Requirements /h3 /brpWill work within the microbiology team, with responsibility to ensure effective and efficient sterility practices, which includes, but not limited to the following: /p /brul /brliOversight of environmental utility monitoring, bioburden and endotoxin testing practices and procedures, creating alignment and standardization across multi sites. /li /brliExecution, 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. /li /brliInterpreting sampling and monitoring data, applying statistical and analysis techniques, to determine control and trending. Identifies and initiates when to take action. /li /brliLead technical input to NC and CAPA resolution within the Microbiology group and across multiple business units / sites. Strong competency in assessment of effectiveness and resulting sterility compliance. Review and approval of CAPA. /li /brliAct as technical lead for microbiology in cross functional groups including product and process issues, rootcausing, projects, initiatives and other business critical forums. /li /brliSubject Matter Expert, audit and review of Supplier quality activities with critical vendors in area of microbiology. /li /brliReview and approval of sterilisation validations and re-qualifications in line with relevant BS EN ISO standards. Assessment of sterility supplier validation. /li /brliContinually identifies opportunity for stabilization of trends, statistical control of processes to allow cost saving. /li /brliMentors and trains team and cross functional groups as required (induction, GMP etc) /li /brliSubject matter expert to internal external regulatory requirements, (including but not limited to European RHQ, Division, Corporate, FDA, ISO, MDD, and individual country regulatory requirements) /li /brliSubject 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. /li /brliCoach, mentor and train other functions in area of sterility and monitoring. /li /brliSupport of, ensure compliance of new products to sites’ sterility standards. Ensure successful integration of products into validated processes. /li /brliOversight approval of biocompatible assessments of components, materials and consumables used in the manufacture of Stryker product. /li /brliProvides 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. /li /brliDemonstrate technical supervisory capabilities and leads projects to completion. /li /br /ul /brh3Qualification Knowledge Skills /h3 /brul /brliBachelor degree Microbiology or equivalent/ related subject required, with 6 years Microbiology related experience /li /brliMinimum of 8 years in Quality/Regulatory Affairs environment. /li /brliExperience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) required. /li /brliLead auditor certification desirable. /li /brliThorough knowledge and understanding of US and International Medical Device Regulations and standards in area of expertise (Microbiology) /li /brliMust possess strong communication, project management and influencing skills as well as have the ability to manage multiple tasks simultaneously. /li /brliKnowledge of trends in industry and reg standards. /li /brliCompetent in presenting problems and their solutions. /li /brliGood financial acumen. /li /brliStrong Project management. /li /brliExperience in leadership/management of people. /li /brliStrong interpersonal skills. /li /brliStrong written and oral communication and negotiations skills. /li /brliStrong in critical thinking and \"outside the box\" thinking. /li /brliHighly developed problem solving skills. /li /brliStrong analytical skills. /li /brliDemonstrated ability to successfully manage and complete projects in a matrix organization. /li /brliDemonstrated ability to work independently. /li /brliExperience in working in a compliance risk situation. /li /brliHigh proficiency in statistal techniques, data review and analysis. /li /brliHigh level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages /li /brliSome travel may be required. /li /brli#IJ /li /br /ul /p #J-18808-Ljbffr