At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Quality **Job Sub** **Function:** R&D/Scientific Quality **Job Category:** People Leader **All Job Posting Locations:** Blackpool, Lancashire, United Kingdom **Job Description:** At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/ J&J MedTech is recruiting for a **Microbiological Quality & Sterility Assurance Manager** reporting to the Sr Mgr Microbiological Quality & Sterility Assurance and to be based in Blackpool (UK). **Description** The Microbiological Quality & Sterility Assurance Manager position is responsible for end-to-end implementation of contamination control and sterility assurance policies and strategies for the DePuy Synthes Blackpool manufacturing site and will assure that Business Unit/Franchise Global Orthopedics programs are aligned with the overall J&J Sterility Assurance programs. The Microbiological Quality & Sterility Assurance Manager will serve as the Blackpool DePuy Synthes technical leader in the areas of aseptic processing, contamination control, sterilization, reprocessing and microbiology. They manage teams to support product development and product manufacturing activities. They set the strategic and tactical direction of the team through the application of technical knowledge and expertise in contamination control, aseptic processing, sterilization processing and industrial microbiology. This position is responsible for compliance to applicable Quality Regulations and standards. This individual will be responsible for activities such as, but not limited to, the following: + **R&D** + providetechnical leadershiponcontamination control and sterility assurancefornewproductdevelopment + ensurecontaminationcontroland sterility assurancesupportfor productdevelopmentteams,prioritizingprojects with productdevelopmentandensuringsupportduringtheproductdevelopmentcycle. + applybestpractices in the selection,investigationandvalidationof asepticmanufacturingandsterilizationmethodologies in accordancewithapplicableregulationsandstandards + ensure design changesmeetcontamination control and sterility assurancerequirements + supportduediligence oncontaminationcontrol and sterility assuranceforacquisitionsandnewproduct licensing + providesupport in thedevelopmentof design history files andregulatorysubmissions to ensure compliance to applicable regulations andstandardsinternationally + drive innovation to providenovelmethodologies,processesorstrategiesforcontaminationcontrol and sterilization. + provide expertise in thedevelopmentofprocessinginstructionsforuse andassociatedvalidationforthe cleaning, disinfection and sterilizationof non-sterile or reusable devices + **Plan** + participate in thedevelopmentandselectionofnewBusinessUnit/Franchisemanufacturingoperations (to includemanufacturing sites andfacilityinvestments,contractsterilization & laboratories,andthird-partymanufacturers) + Support business acquisitions and divestures as required. + **Source** + participate in BusinessUnit/Franchisedue diligencefor sterile, non-sterileormicrobiologicallycontrolledmanufactured products, andprovidetechnicalSMEsupportforintegrationintoJ&J + providetechnicalSMEsupportforprocurement activities that relate to sterile, non- sterile ormicrobiologicallycontrolled productsthat are externally manufactured + provide input in the design ofnewmanufacturing processes, controlledenvironmentsandpackaging from a microbiological,terminalsterilizationandreprocessingstandpoint + provide input for the design ofBusinessUnit/Franchisecritical waterand air systemsandthe design ofcontrolledenvironmentsand cleanliness control strategies + **Make** + providetechnicalleadershiponcontamination control and sterility assurance at BusinessUnit/Franchise manufacturingfacilities + maintainknowledgeofbestpractices,standardsandguidance in sterilization,processing,aseptictechnique andenvironmentalmonitoring.EnsureBusinessUnit/Franchise policiesandprocedures are maintained to ensure compliance. + developandmaintainBusiness Unit/Franchiseor facility-specificguidelines andstandardsfor contaminationcontroland sterility assurance in accordancewithfranchise,corporateandapplicableinternationalstandards + ensureprocesschangesmeetcontaminationcontroland sterility assurancerequirements + manages anddispositions microbiologicalor contaminationcontrol CAPAs and non- conformances,including rootcauseidentificationandcorrectiveactionimplantationwithin agreed timelines + supportstechnicalassessmentsofthirdpartymanufacturers,sterilizationcontractors, external laboratoriesandother applicablesuppliers. + provideleadershipandsupportduring facilityaudits + maintaincloseinvolvement/alignment with the local SterilizationExecutionorganization to supportthe release of sterile product, and addressinganyissues thatmight arise during theexecutionofthesterilizationprocesses + Support wider manufacturing engagement with external manufacturers to ensure J&J best practices are being adhered to + **Deliver** + customer engagement andsupport,monitoringtrends in Customerneedswithfeedback to Management + **External** **Influencing** + identifies external opportunities to influencebestpractices in sterility assuranceandcontaminationcontrolbyinteractingwithregulators,standard/guidelineorganizations, research andacademicinstitutions. + Engage with external industry experts to support the development of new and revised regulatory standards + **Internal** **Influencing** + interactswithbusiness leaders to ensure objectivesandprojectprioritizationmeetbusinessneeds.Interactswiththeir peers in sterility assurance to utilizeresourcesand ensure bestpracticesacrossfacilities. + Actively participate and assume leadership positionontheJ&JSterilityAssuranceCouncils + Provide training and mentorship to J&J MQSA personnel across all franchises in sterilization best practices within Gas, Heat and novel modalities + **Sterilization Supply Chain Sustainability** + Provide technical leadership in the establishment of a robust supply chain for sterilization for DePuy Synthes and wider J&J franchises + Identification and exploration of novel sterilisation modalities, evaluating their suitability and supporting their deployment within DePuy Synthes and wider J&J franchises + Provide regional support to JJMQSA Tiger Teams in the realization of their sterilization objectives. The technical areas overseen by the Microbiological Quality & Sterility Assurance Manager include: aseptic processing, cleaning and disinfection requirements, sterilization validation (for EO, gamma, electron beam, x-ray, moist heat, and dry heat processes), reprocessing, microbiological testing to support the validation and maintenance of the sterilization processes and product label claims (e.g., bioburden, tests of sterility, endotoxin monitoring), environmental control and monitoring, water and air systems validation, sterility assurance support to new product development and launch, compliance to applicable regulations and standards in the subject areas of sterility assurance and laboratories. Inspection and submission support and Health based risk assessment. The Microbiological Quality & Sterility Assurance Manager will also be responsible to ensure the development of their team to include career development, work-life balance, succession planning etc. qualified candidates will have experience in microbiology, sterilization validation (terminal, aseptic, and/or reprocessing) and environmental controls for a medical device or pharmaceutical manufacturing facility demonstrated capability to lead and train a large and diverse, multinational community with multiple stakeholders, working in a supervisory, coaching, mentoring and/or influencing capacity must have a strong understanding of product design, quality and manufacturing processes. proven track record on troubleshooting process non-conformances and out of specification test results, and providing resolution to issues by a robust CAPA process experience in interacting with Regulatory Authorities is preferred experience with conducting technical assessments of in-house and external manufacturing and terminal sterilization is preferred strong knowledge of standards including EU, USA and ISO is required strong teamwork and communication skills to work effectively on cross-functional project teams, interacting with a diversity of disciplines such as R & D, Packaging Engineering, Quality Engineering, Regulatory Affairs, Marketing, etc. independent organizational and time management skills is required **Education** **and** **Experience:** + an undergraduate (BS) degreewithMicrobiology,Biology,Engineeringor related discipline is required; an advanced degree is desirable. + a minimumof 8 years of experience in a medicaldeviceorpharmaceutical(combination)industrywith a GMPand/or ISO regulatedenvironment is required. + proventrackrecord in team management + competent in using computersoftwaresuch as Excel, Word andPowerPoint, and analytical software.