{"id":1211197,"url":"https://alion.io/job/sartorius-qe-sterilization-validation","title":"QE-Sterilization validation","company":{"id":1796190,"name":"Sartorius","domain":"sartorius.com","url":"https://alion.io/company/sartorius-com","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"junior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":["Incheon, South Korea"],"countries":["KR"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":35000,"max_usd":76000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":1608},"experience_years_min":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-09-23T00:00:00Z","employer_posted_date":"2026-09-23","last_verified_at":"2026-09-25T16:45:43Z","board_verified":true,"closed_at":null,"days_open":3,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":3},"description":"As the Sterility Validation Quality Engineer, you will be responsible for sterility of the Single use solution products using basic skills and strong technical knowledge of appropriate standards, procedures, methods, techniques, as well as applicable current good manufacturing practice and state of the art.As the Sterility Validation Quality Engineer, you will be responsible for sterility of the Single use solution products using basic skills and strong technical knowledge of appropriate standards, procedures, methods, techniques, as well as applicable current good manufacturing practice and state of the art.\nResponsibilities\nDevelop the strategy, implement and optimize validation of sterility as per state of the art and current applicable standards\nEstablish and lead the plan and coordinate project at local site based on global process\nSupport validation maintenance as per describe in the validation plan and procedures\nTrain on local manufacturing sites\nSupport customer audit and inspection\nWrite and review Standard Operating Procedures (SOPs)\nSupport ongoing process improvement endeavors\nProvide support for new internal and sponsored projects including reviewing protocols and reports\nProvide support in the management of OOS\nProvide data for sterilization validation for US DMF Type III submitted by Compliance Team\nIn charge of sterilization suppliers qualification audit based on existing process \nActs towards FMT objectives in terms of Compliance and Quality\nHas got a full autonomy to organize and execute her tasks, under the supervision of the Site Quality manager\nDevelop testing, technical survey, best practices according to the regulations & state of the art\nOrganize and conduct validation plan according to European and US Quality standards and internal documentation and Quality procedures\nInterfaces\nLocal: Operation, Engineering, MSAT Supply Chain, Logistics etc. \nGlobal: Other Sartorius site contact mainly located in France, German, US and China.\nQualifications & Requirements\nBachelor's degree in microbiology, biotechnology Engineering or related field\nGamma irradiation, X-ray sterilization process knowledge and practical experience is the must\n5 years of relevant work experience, including 2+ years of experience in pharmaceutical or medical devices environment\nKnowledge of requirements and relevant industry standard practices with a demonstrated ability to interpret these regulations to ensure proper implementation in the quality systems\nAbility to quickly acquire organizational skills, including the ability to manage multiple processes and priorities effectively assess assigned task requirements to transversal, identify potential challenges, and communicate effectively to expedite the successful execution of assigned work\nBe a force of proposal within the framework of strategic approaches\nPerfect command of English\nPreference\nProject participation experience related to facility qualification is a strongly preferred.\nWork experience work in or with multinational healthcare industry\nExperienced with eQMS and SAP based work environment\nSelf-motivated, entrepreneurship, enjoying exploring new technology (IT tools)\nAbout Sartorius\nSartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide.\nWe look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment.\nJoin our global team and become part of the solution. We are looking forward to receiving your application. \nwww.sartorius.com/careers","description_format":"text","description_chars":3717,"description_truncated":false,"requirements":{"experience_years_min":2,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"All levels","optional":false}]},"benefits":[],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"},{"name":"China","iso":"CN","kind":"country"},{"name":"France","iso":"FR","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Laboratory Equipment","Bioprocessing"],"lifecycle":[{"event":"open","at":"2026-09-25T04:26:23Z"}],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":2,"expected_fill_days":14,"reasons":["conf:0","win:early","comp:junior,brand"],"computed_at":"2026-09-25T05:45:01Z"},"pay":null,"html_url":"https://alion.io/job/sartorius-qe-sterilization-validation","json_url":"https://alion.io/job/sartorius-qe-sterilization-validation.json","meta":{"generated_at":"2026-09-26T00:10:13Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","usage":{"tier":"crawler","counted_by":"address","units_charged":1,"used_today":54,"day_limit":5000,"remaining_today":4946,"minute_limit":60,"resets_at":"2026-09-27T00:00:00Z"}}}