{"data":{"id":215674,"slug":"sterility-assurance-lead","type":"job","title":"Sterility Assurance Lead","description":"About the Role\nWe are seeking a Sterility Assurance Lead to own and drive the site's strategy for sterility assurance. The role ensures compliance with global regulatory requirements and serves as an SME for contamination control, aseptic processing, and sterilization validation.\n\nKey Responsibilities:\nLead the Sterility Assurance Program (SAP) and Contamination Control Strategy (CCS) in accordance with EU GMP Annex 1 and global standards.\n\n\nOversee environmental monitoring, cleanroom qualification, and aseptic methods.\n\n\nReview sterilization validations and lead media fill programs.\n\n\nDrive contamination risk assessments, investigations, and CAPA.\n\n\nServe as an SME during audits and inspections.\n\n\nProvide training and mentorship in sterility assurance best practices.\n\nYour Profile\nYou are a highly motivated sterility assurance specialist with a strong quality mindset and a genuine commitment to patient safety. You combine deep technical expertise with leadership capabilities and are comfortable serving as the site's Subject Matter Expert. You thrive rather than struggle in a fast-growing environment and contribute with a proactive and solution-oriented approach that allows you to identify risks early, drive improvements, and maintain operational excellence even when priorities shift.\nYou work well in a collaborative, cross-functional environment and can communicate complex technical topics clearly to both technical and non-technical stakeholders. You are confident in leading investigations, coaching colleagues, and driving initiatives that strengthen contamination control and aseptic manufacturing\u2014and you see this growth phase as an opportunity to grow in your own role.\n\nRequirements:\nBachelor's or Master's degree in microbiology, biotechnology, pharmacy, or another relevant life sciences field.\n\n\nAt least 8 years of experience in sterile manufacturing, microbiology, or sterility assurance within the pharmaceutical, biologics, or medical device industry.\n\n\nProven experience in GMP-regulated environments and support during regulatory inspections and audits.\n\n\nPractical experience with contamination control strategies, environmental monitoring programs, and aseptic manufacturing operations.\n\nCompetencies:\nDeep technical expertise in aseptic processing, sterilization techniques (moist heat, dry heat, filtration), and microbial contamination control.\n\n\nStrong knowledge of cleanroom operations, HVAC qualification, isolators\/RABS, and environmental monitoring systems.\n\n\nGood understanding of EU GMP Annex 1 and familiarity with global regulatory requirements (FDA, EMA, PIC\/S).\n\n\nExperience with risk assessments using tools such as FMEA, HACCP, or similar methodologies.\n\n\nStrong analytical thinking with the ability to interpret data trends and drive continuous improvement initiatives.\n\n\nExcellent documentation skills and a structured approach to problem-solving and investigations.\n\n\nStrong communication and collaboration skills with the ability to influence cross-functional teams.\n\nApplication\nIf you believe this is the right opportunity for you, please submit your application as soon as possible. We evaluate applications on a rolling basis, so do not delay submitting your application. If you have questions about the role or the recruitment process, please feel free to contact Charlotte Duvefelt, charlotte.duvefelt@sallyq.se.","language":"sv","is_translated":true,"title_original":"Sterility Assurance Lead","description_original":"Om rollen\nVi s\u00f6ker en Sterility Assurance Lead som ska \u00e4ga och driva platsens strategi f\u00f6r sterilitetss\u00e4kring. Rollen s\u00e4kerst\u00e4ller efterlevnad av globala regulatoriska krav och fungerar som SME f\u00f6r kontaminationskontroll, aseptisk bearbetning och steriliseringsvalidering.\nHuvudsakliga arbetsuppgifter:\nLeda Sterility Assurance Program (SAP) och Contamination Control Strategy (CCS) i enlighet med EU GMP Annex 1 och globala standarder.\n\n\n\u00d6vervaka milj\u00f6\u00f6vervakning, renrumskvalificering och aseptiska metoder.\n\n\nGranska steriliseringsvalideringar och leda media fill-program.\n\n\nDriva riskbed\u00f6mningar f\u00f6r kontamination, utredningar och CAPA.\n\n\nAgera som SME vid audits och inspektioner.\n\n\nGe utbildning och mentorskap inom b\u00e4sta praxis f\u00f6r sterilitetss\u00e4kring.\n\nDin profil\nDu \u00e4r en h\u00f6gmotiverad specialist inom sterilitetss\u00e4kring med ett starkt kvalitetst\u00e4nk och ett brinnande intresse f\u00f6r patients\u00e4kerhet. Du kombinerar djup teknisk expertis med ledarskapsf\u00f6rm\u00e5ga och \u00e4r bekv\u00e4m med att agera som platsens Subject Matter Expert. Du energiseras snarare \u00e4n st\u00f6rs av en snabbv\u00e4xande milj\u00f6 och bidrar med ett proaktivt och l\u00f6sningsorienterat f\u00f6rh\u00e5llningss\u00e4tt som g\u00f6r att du identifierar risker tidigt, driver f\u00f6rb\u00e4ttringar och uppr\u00e4tth\u00e5ller operativ excellens \u00e4ven n\u00e4r prioriteringar f\u00f6r\u00e4ndras.\nDu trivs i en samarbetsinriktad och tv\u00e4rfunktionell milj\u00f6 och kan kommunicera komplexa tekniska fr\u00e5gor tydligt till b\u00e5de tekniska och icke-tekniska intressenter. Du \u00e4r trygg i att leda utredningar, coacha kollegor och driva initiativ som st\u00e4rker kontaminationskontroll och aseptisk tillverkning \u2013 och du ser denna tillv\u00e4xtfas som en m\u00f6jlighet att v\u00e4xa i din egen roll.\nKrav:\nKandidat- eller masterexamen inom mikrobiologi, bioteknik, farmaci eller annat relevant Life Science-omr\u00e5de.\n\n\nMinst 8 \u00e5rs erfarenhet inom steril tillverkning, mikrobiologi eller sterilitetss\u00e4kring inom l\u00e4kemedels-, biologics- eller medicinteknisk industri.\n\n\nBevisad erfarenhet av GMP-reglerade milj\u00f6er och st\u00f6d vid regulatoriska inspektioner och audits.\n\n\nPraktisk erfarenhet av kontaminationskontrollstrategier, milj\u00f6\u00f6vervakningsprogram och aseptiska tillverkningsoperationer.\n\nKompetenser:\nDjup teknisk expertis inom aseptisk bearbetning, steriliseringstekniker (fuktig v\u00e4rme, torr v\u00e4rme, filtrering) och mikrobiell kontaminationskontroll.\n\n\nStark kunskap om renrumsoperationer, HVAC-kvalificering, isolatorer\/RABS och milj\u00f6\u00f6vervakningssystem.\n\n\nGod f\u00f6rst\u00e5else f\u00f6r EU GMP Annex 1 och k\u00e4nnedom om globala regulatoriska krav (FDA, EMA, PIC\/S).\n\n\nErfarenhet av riskbed\u00f6mningar med verktyg som FMEA, HACCP eller liknande metoder.\n\n\nStarkt analytiskt t\u00e4nkande med f\u00f6rm\u00e5ga att tolka datatrender och driva st\u00e4ndiga f\u00f6rb\u00e4ttringsinitiativ.\n\n\nUtm\u00e4rkta dokumentationsf\u00e4rdigheter och ett strukturerat f\u00f6rh\u00e5llningss\u00e4tt till probleml\u00f6sning och utredningar.\n\n\nStarka kommunikations- och samarbetsf\u00e4rdigheter med f\u00f6rm\u00e5ga att p\u00e5verka tv\u00e4rfunktionella team.\n\nAns\u00f6kan\nOm du tror att detta \u00e4r r\u00e4tt m\u00f6jlighet f\u00f6r dig, skicka in din ans\u00f6kan s\u00e5 snart som m\u00f6jligt. Vi utv\u00e4rderar ans\u00f6kningar l\u00f6pande s\u00e5 v\u00e4nta inte med att skicka in din ans\u00f6kan. Har du fr\u00e5gor om rollen eller rekryteringsprocessen \u00e4r du varmt v\u00e4lkommen att kontakta Charlotte Duvefelt, charlotte.duvefelt@sallyq.se.","available_locales":["en"],"price":null,"currency":"SEK","status":"active","noindex":true,"location":{"address":null,"full_address":null,"city":"Uppsala","country":"SE","latitude":59.858610353291,"longitude":17.641048437756},"metadata":{"region":"Uppsala l\u00e4n","duration":"Tills vidare","employer":"SallyQ AB","postcode":"75320","positions":1,"profession":"Mikrobiolog","salary_type":"Fast m\u00e5nads- vecko- eller timl\u00f6n","employer_url":"https:\/\/sallyqab.teamtailor.com","scope_of_work":"100\u2013100 %","working_hours":"Heltid","employment_type":"full_time","occupation_field":"Naturvetenskap","employer_workplace":"SallyQ AB","experience_required":true,"employment_type_label":"Vanlig anst\u00e4llning"},"user_id":null,"is_sponsored":false,"views_count":0,"ai_views_count":3,"bot_views_count":2,"ai_vendor_counts":{"openai":2,"anthropic":1},"visibility":"public","submission_source":null,"submission_ai_name":null,"has_owner_email":true,"can_contact_owner":true,"phone":null,"owner_email":"charlotte.duvefelt@sallyq.se","images":[],"published_at":"2026-09-16T15:08:21+00:00","expires_at":"2027-03-15T23:59:59+00:00","created_at":"2026-09-17T03:55:43+00:00","updated_at":"2026-09-22T03:01:38+00:00"}}