{"id":1887302,"url":"https://alion.io/job/bayer-staff-engineer-for-sterility-assurance","title":"Staff Engineer for Sterility Assurance","company":{"id":671164,"name":"Bayer","domain":"bayer.com","url":"https://alion.io/company/bayer-7","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"SuccessFactors","truth_index":{"grade":"A","score":100,"open_postings":4,"ghost_share":0,"stale_share":0,"repost_share":0,"time_to_fill_p50_days":11,"computed_at":"2026-10-20T05:45:00Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"staff","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"inferred","locations":["Indianola, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":96480,"max":144720,"currency":"USD","period":"year","gross":null,"usd_annual":144720},"salary_estimate":null,"experience_years_min":7,"visa_sponsorship":true,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-10-05T03:07:18Z","employer_posted_date":"2026-10-05","last_verified_at":"2026-10-20T03:38:20Z","board_verified":true,"closed_at":null,"days_open":15,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":15},"description":"At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where 'Health for all Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.\nStaff Engineer for Sterility Assurance\nStaff Engineer - Sterility Assurance\nPURPOSE\nThis role serves as a global technical lead for sterilization and microbiology, providing scientific expertise and leadership to support the development, validation, implementation, and maintenance of sterilization processes for medical devices and combination products. The position works across the product lifecycle, from new product development (NPD) through launched product sustainment (LCE), ensuring compliance with regulatory requirements while supporting manufacturing operations worldwide. - No Sponsorship is available for this position.\nYOUR RESPONSIBILITIES AND TASKS\nDefines requirements at the project level to develop, validated and implement sterilization solutions applicable to combination product and medical device manufacturing operations;\nProactively provides expertise and/or technical scientific leadership related to sterilization, microbiology, and biological safety to cross-functional teams including New product development (NPD), Life cycle engineering (LCE), external partners, internal operations, and manufacturing plant staff. Ensures that project deliverables and activities are completed on time with minimal production disruption;\nPlans and coordinates technical and analytical testing to support sterility assurance. Creates validation plans and reports and reviews the validation activities performed by Bayer and suppliers;\nProvides technical expertise and scientific leadership across projects with respect to designing for sterilization (R&D) and launched product/process sustainment (LCE). This includes troubleshooting and root cause analysis for issues related to sterilization processes globally;\nOptimizes sterilization processes to enable time and cost savings;\nInitiates and maintains strategic sterilization partnerships globally and relationships with key individuals of other organizations by providing technical support and co-operation with the suppliers;\nAnalyzes problems and synthesizes solutions, exhibiting creativity, foresight, innovation, and judgment in anticipating and solving these problems. Consistently applies complex analytical methods combined to scientific thinking and experimental concepts for solutions supporting data driven decision making;\nCreates and reviews plans, reports, SOPs, risk assessments, change controls, design controls, process specifications, sterilization process records, regulatory documents, third party documents and supplier audits related to the area of responsibility;\nPlans and manages own work activities of significant technical scope with minimal direction;\nDevelops and executes new EO and irradiation sterilization validations;\nMaintains sterilization process validations (e.g., quarterly dose audits, annual re-validation of EO sterilization);\nResponds to health/regulatory authority inquiries related to sterility assurance of combination products and medical devices;\nServes as SME for sterilization for New Product Development projects;\nInvestigates and documents sterilization process non-conformances and drives corrective actions in coordination with manufacturing site quality teams;\nConducts data analysis, trending, and reporting to management;\nDevelopment and integration of policies and procedures (P&P);\nWrites technical procedures, test protocols and reports;\nSeeks new challenges and open to challenge status quo;\nDriven in personal development;\nPromotes knowledge transfer and sharing of best practices;\nMentors and coaches junior scientists, engineers, and technicians;\nDocuments change control activities and related risks assessments;\nFlexible, open to innovative ideas and strategies;\nThis role has frequent internal and external company contacts. The incumbent represents the organization on specific projects including new-product development, product lifecycle initiatives, and the overall sterilization network. This role has inter-organizational, outside customer and vendor contacts on routine matters; \nThis role may require international travel (less than 20%) to support global projects;\nThis role also periodically requires flexing work hours outside of the standard hours in order to support global projects and team members in differing time zones. \nWHO YOU ARE\nBayer seeks an incumbent who possesses the following:\nREQUIRED QUALIFICATIONS\nBachelor’s degree required (e.g., engineering or science-based degree);\nPrevious work experience in medical device manufacturing;\nDemonstrated knowledge and application of engineering and scientific concepts within medical device;\nEffectively manages multiple concurrent projects. Understands priorities of assigned tasks and plans daily activities accordingly. Develops creative solutions to challenging and novel problems under minimal or no direction, exhibiting creativity, foresight, innovation and judgment in anticipating and solving these problems;\nEngineering knowledge crossing into multiple technical disciplines. (For Example: Engineering, quality assurance, R&D, regulatory);\nDemonstrates analytical capabilities including statistical analysis and problem-solving techniques;\nAble to write and apply relevant policies and procedures (P&P) based on regulations and industry standards;\nAble to present technical concepts to laypersons and management;\nDemonstrates ability to lead teams and coordinate disparate groups to achieve project goals;\nApproaches challenging situations with an open mind and demonstrates personal drive to discover solutions that are beneficial to the entire project team.\nPREFERRED QUALIFICATIONS\nMaster of Science degree;\n7 years minimum work experience in medical device manufacturing, sterilization, microbiology, toxicology, validation, product development, or quality is strongly preferred;\nExperience in Ethylene Oxide sterilization process development and validation; adoption of new products to existing processes;\nExperience in Radiation sterilization process development and validation (Electron beam, Gamma and x-Ray included); adoption of new products to existing processes;\nDemonstrates understanding of biocompatibility and sterilization standards and regulatory requirements for drug products and medical devices. Biocompatibility testing experience and demonstrated familiarity with ISO 10993 and related standards;\nKnowledge of material characterization and compatibility with sterilization modalities.\nEmployees can expect to be paid a salary between $96,480.00 to $144,720.00. Additional compensation may include a bonus or incentive compensation (if relevant). Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc..\nThis salary range is merely an estimate and may vary based on an applicant’s location, market data/ranges, an applicant’s skills and prior relevant experience, certain degrees and certifications, and other relevant factors.\nThis posting will be available for application until at least 9-15-26.\n\n YOUR APPLICATION\n\nBayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and want to impact our mission Health for all, Hunger for none, we encourage you to apply now. Be part of something bigger. Be you. Be Bayer.\nTo all recruitment agencies: Bayer does not accept unsolicited third party resumes.\nBayer is an Equal Opportunity Employer/Disabled/Veterans\nBayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.\n\nEqual Opportunity Employer Statement: Notice for U.S. Visitors: All information on this site is subject to compliance with local rule and regulations as they may vary from time to time and across different geographies, including, without limitation, U.S. Executive Orders.\n\nBayer is an E-Verify Employer.\n\nLocation:\nUnited States : Pennsylvania : Indianola \n\nDivision:\nPharmaceuticals \n\nReference Code:\n883592 \n\nContact Us\n\n Email:\n","description_format":"text","description_chars":8688,"description_truncated":false,"requirements":{"experience_years_min":7,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":true},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Farming & Agriculture","Health Care","Crop Protection","OTC & Consumer Health Products"],"lifecycle":[{"event":"open","at":"2026-10-05T03:07:18Z"}],"visa":[{"country":"GB","licensed_sponsor":true,"evidence":"Licensed UK visa sponsor (Senior or Specialist Worker, Skilled Worker)","filings_12m":null,"filings_prev_12m":null,"green_card_filings_12m":null,"median_offered_wage_usd":null,"route":"Global Business Mobility: Senior or Specialist Worker; Skilled Worker","cap_exempt":false,"checked_at":"2026-10-20T06:21:30+00:00","sources":["UK Home Office: register of licensed sponsors (workers)"],"filings_for_role_12m":0}],"liveness":{"score":42,"band":"fade","label":"Fading","p_open":1,"p_active":0.761,"p_room":0.55,"age_days":15,"expected_fill_days":11,"reasons":["conf:2","velocity","win:tail","comp:brand"],"computed_at":"2026-10-20T05:45:00Z"},"pay":{"stated_usd_annual":144720,"is_top_pay":false},"html_url":"https://alion.io/job/bayer-staff-engineer-for-sterility-assurance","json_url":"https://alion.io/job/bayer-staff-engineer-for-sterility-assurance.json","meta":{"generated_at":"2026-10-20T07:02:07Z","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":7683,"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":671164},"rest":"https://alion.io/mcp/rest/get_company?id=671164"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fbayer-staff-engineer-for-sterility-assurance"},{"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%2Fbayer-staff-engineer-for-sterility-assurance"},{"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%2Fbayer-staff-engineer-for-sterility-assurance"},{"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/bayer-staff-engineer-for-sterility-assurance\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fbayer-staff-engineer-for-sterility-assurance"}]}