Senior staff microbiologist

Ph3Hybrid Senior Staff Microbiologist – 12 month fixed term contract /h3pWork Flexibility: Hybrid /ppPosition Overview /ppThe Senior Staff Microbiologist will provide technical input into the sterility compliance of Stryker products in accordance with relevant regulatory requirements and standards for medical devices, at a multi‑site / global level. The role is not lab based and requires oversight across multiple sites. /ph3Responsibilities /h3ulliOversee environmental and utility monitoring, bioburden and endotoxin testing practices and procedures, creating alignment and standardization across multi‑sites. /liliExecute, review, and approve Gamma and Ethylene Oxide sterilisation validations and re‑qualifications in line with BS EN ISO standards. /liliAssess and validate sterility supplier validation programmes. /liliInterpret sampling and monitoring data, apply statistical and analytical techniques to determine control, trending and identify when action is required. /liliLead technical input to NC and CAPA resolution within the Microbiology group and across multiple business units/sites, and review and approve CAPA. /liliAct as the technical lead for microbiology in cross‑functional groups including product and process issues, root‑causing, projects, initiatives and business critical forums. /liliServe as subject‑matter expert on audit and review of supplier quality activities with critical vendors in microbiology. /liliMentor and train team members and cross‑functional groups (induction, GMP, etc.). /liliProvide technical assessment for risk assessment (e.g., SofHA) in sterility and microbiology. /liliAssess and approve acceptance of resolution to quality issues, including concession management. /liliSupport new product compliance with sites’ sterility standards and ensure successful integration into validated processes. /liliOversight and approval of biocompatible assessments of components, materials and consumables used in Stryker product manufacturing. /liliDemonstrate technical supervisory capabilities and lead projects to completion. /li /ulh3Qualifications /h3ulliBachelor’s degree in Microbiology or an equivalent related subject. /liliMinimum 6 years of microbiology‑related experience and a total of 8 years in a quality/regulatory affairs environment. /liliExperience interacting with regulatory agencies (e.g., FDA, MoH, TUV). /liliDesirable: Lead Auditor certification. /liliIn‑depth knowledge of US and international medical device regulations and standards in microbiology. /liliStrong communication, project management and influencing skills; ability to manage multiple tasks simultaneously. /liliLeadership/management experience with people, strong interpersonal and written/oral communication skills. /liliAnalytical and critical‑thinking skills, including proficiency in statistical techniques, data review and analysis. /liliProficient with Microsoft Word, Excel and PowerPoint. /liliExperience working in a compliance‑risk environment, leading and completing projects in a matrix organisation. /li /ulh3Travel Flexibility /h3ulliTravel may be required – up to 10% of the time. /liliHybrid work model: regular work both in an alternate workplace and at a Stryker facility. /li /ul /p #J-18808-Ljbffr