{"id":1905016,"url":"https://alion.io/job/lifecore-biomedical-senior-sterility-assurance-engineer","title":"Senior Sterility Assurance Engineer","company":{"id":2341566,"name":"Lifecore Biomedical","domain":"lifecore.com","url":"https://alion.io/company/life-core","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"ADP","truth_index":{"grade":"A","score":100,"open_postings":3,"ghost_share":0,"stale_share":0,"repost_share":0,"time_to_fill_p50_days":33,"computed_at":"2026-10-19T05:45:15Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Chaska, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":95000,"max":110000,"currency":"USD","period":"year","gross":null,"usd_annual":110000},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-08-20T13:41:00Z","employer_posted_date":"2026-10-07","last_verified_at":"2026-10-19T23:54:58Z","board_verified":true,"closed_at":null,"days_open":60,"trust":{"level":"ok","repost_count":1,"flags":[],"days_open":59},"description":"It's not what we make. It's what we make possible and the possibilities at Lifecore are endless!\nThis full time position offers incredible benefits, your choice of a 4 ½ or 5 day work week, and a company culture focused on development and growth which include promotion opportunities.\nAs a Senior Sterility Assurance Engineer you will define, execute, review/approve and summarize Aseptic Process Simulations, Cleaning Validation, Smoke Studies, Secondary Sterilization activities (eg EtO), etc. including investigations into failures. You will use quality engineering concepts to monitor, support, and critically review changes or issues to existing validated aseptic processes.\nThis position is eligible for a hybrid work schedule, with up to 2 to 3 remote workdays per week based on business needs. Employees are expected to work on-site as required for meetings, client visits, audits, and other responsibilities that benefit from in-person collaboration and support.\nIn this critical engineering role you’ll have the opportunity to:\nCreate and coordinate execution of sterility assurance and aseptic process validation protocols including but not limited to: Smoke studies\nMedia Fills\nSteam sterilization\nSecondary sterilization\nCleaning disinfectant efficacy\n\nPerform risk assessment (FMEA) on new/changed equipment and processes and procedures\nProvide knowledge leadership and technical expertise for validations and investigations\nProvide technical expertise in support of audits. \nThis position could be a great fit for you if you have excellent organizational skills and the capability to manage multiple, dynamic cross functional projects simultaneously, along with the following:\nBS in Engineering or Life Sciences \n5-8 years of Sterility Assurance or Quality Engineering experience\nExperience with aseptic filling and cleaning validation. \nBackground in pharmaceutical, biotechnology and/or chemistry production a strong plus!\nStarting Salary: $95,000 - $110,000 annually with consideration for relevant skills and experience\nLifecore offers a highly competitive total rewards package, including:\nOpportunities to learn and grow with a well-respected company\nCompetitive compensation with annual reviews and a company-wide incentive bonus\nBenefits that start the first of the month after you join Lifecore as a full-time employee:3 medical insurance plans to fit your needs and budget including an HSA Plan with company contributions.\nLow cost dental and vision insurance\nShort term disability, long term disability and life insurance all 100% company paid\n3 weeks PTO in the first year (increases to 4 weeks after just 2 years!)\n9 paid company holidays plus 2 personal holidays\nPaid family leave\nTuition reimbursement\n401k plan with company matching contribution\n\nMeet Lifecore Biomedical, LLC:\nLifecore Biomedical, Inc. (Nasdaq: LFCR) is a fully integrated contract development and manufacturing organization (CDMO) that offers highly differentiated capabilities in the development, fill and finish of sterile injectable pharmaceutical products in syringes, vials, and cartridges, including complex formulations. As a leading manufacturer of premium, injectable-grade hyaluronic acid, Lifecore brings more than 40 years of expertise as a partner for global and emerging biopharmaceutical and biotechnology companies across multiple therapeutic categories.","description_format":"text","description_chars":3370,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["401k plan","Health insurance","Hybrid work","Life insurance","Parental leave","Vision insurance"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Health Care","Health & Medical Electronics","APIs & Drug Manufacturing"],"lifecycle":[{"event":"open","at":"2026-10-05T12:36:04Z"},{"event":"close","at":"2026-10-06T21:02:03Z"},{"event":"reopen","at":"2026-10-07T23:48:12Z"}],"visa":[],"liveness":{"score":24,"band":"cold","label":"Long shot","p_open":1,"p_active":0.537,"p_room":0.45,"age_days":59,"expected_fill_days":33,"reasons":["conf:1","win:tail"],"computed_at":"2026-10-19T05:45:15Z"},"pay":{"stated_usd_annual":110000,"is_top_pay":false},"html_url":"https://alion.io/job/lifecore-biomedical-senior-sterility-assurance-engineer","json_url":"https://alion.io/job/lifecore-biomedical-senior-sterility-assurance-engineer.json","meta":{"generated_at":"2026-10-20T00:24:57Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":431,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-21T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":2341566},"rest":"https://alion.io/mcp/rest/get_company?id=2341566"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Flifecore-biomedical-senior-sterility-assurance-engineer"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Flifecore-biomedical-senior-sterility-assurance-engineer"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Flifecore-biomedical-senior-sterility-assurance-engineer"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/lifecore-biomedical-senior-sterility-assurance-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Flifecore-biomedical-senior-sterility-assurance-engineer"}]}