{"id":1162732,"url":"https://alion.io/job/edwards-lifesciences-senior-microbiologist","title":"Senior Microbiologist","company":{"id":5220,"name":"Edwards Lifesciences","domain":"edwards.com","url":"https://alion.io/company/edwards","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":79,"open_postings":50,"ghost_share":0,"stale_share":0.8,"repost_share":0.04,"time_to_fill_p50_days":28,"computed_at":"2026-10-26T05:57:25Z"}},"role":"Science & Research","role_family":"Science & Research","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":92000,"max":130000,"currency":"USD","period":"year","gross":null,"usd_annual":130000},"salary_estimate":null,"experience_years_min":4,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Microsoft Office","optional":false}],"status":"closed","first_seen_at":"2026-09-23T00:00:00Z","employer_posted_date":"2026-09-23","last_verified_at":"2026-10-19T11:08:31Z","board_verified":false,"closed_at":"2026-10-19T11:08:31Z","days_open":26,"trust":{"level":"not_scored","repost_count":null,"flags":[],"days_open":26},"description":"Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology. \nAortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.\nThe Senior Microbiologist provides technical leadership for sterilization, sterility assurance, antimicrobial control, and environmental monitoring programs supporting medical device manufacturing. This role leads cross-functional validation and qualification studies, develops complex microbiological protocols and methods, performs advanced data analysis and trend evaluation, and drives corrective and preventive actions to ensure compliance with regulatory, quality, and Edwards standards. The position serves as a subject-matter expert in microbiological controls and supports continuous improvement initiatives across laboratory and manufacturing operations.\nHow you will make an impact:\nServe as a technical lead and/or subject matter expert for microbiological testing, including bioburden, sterility, endotoxin, antimicrobial testing, environmental monitoring, in process solutions, and raw material evaluation.\nPerform, review, and approve routine and non routine microbiological testing activities to ensure methods are executed correctly and data are scientifically sound.\nApply advanced microbiology principles to assess method suitability, organism recovery, incubation parameters, media performance, and identification approaches.\nProvide authoritative guidance on atypical results, OOS/OOT trends, and borderline or ambiguous microbiological data.\nAct as the microbiology SME for cleanroom and controlled environment monitoring programs, including viable and non viable particulate monitoring.\nLead and support qualification, validation, and ongoing monitoring of critical systems (e.g., cleanrooms, utilities, microbiology related manufacturing systems).\nLead and support establishment, justification, and evaluation of EM alert and action limits, excursion assessments, and remediation effectiveness.\nParticipate in change impact assessments related to environmental controls, disinfection programs, cleanroom design, and manufacturing systems\nEnsure microbiology activities are performed in compliance with ISO standards, FDA QSR, GMP, and Edward’s quality management procedures.\nLead microbiology related investigations (e.g., OOS, OOT, EM excursions, sterility failures), ensuring root cause analyses are well supported and corrective actions are effective.\nApply and reinforce Good Documentation Practices (GDP) across all microbiology records, reports, protocols, and laboratory data systems.\nIdentify gaps, inconsistencies, or risks within microbiology processes and initiate corrective actions through established QMS mechanisms.\nAuthor, review, and approve microbiology SOPs, work instructions, protocols, and reports within scope of responsibility.\nApply strong working knowledge of ISO microbiological and sterilization standards to laboratory testing, environmental monitoring programs, and validation activities.\nTranslate regulatory and standard requirements into clear, executable laboratory practices.\nSupport internal and external audits and inspections by presenting microbiology data, rationale, and controls accurately and confidently.\nExecute and support microbiological method validation and verification activities in alignment with approved validation strategies.\nSupport qualification, calibration, and maintenance of microbiology laboratory equipment.\nReview and assess proposed changes to microbiology methods, equipment, materials, or processes for quality and compliance impact.\nProvide hands on technical guidance and mentoring to technicians, technologists, and junior microbiologists.\nSupport training, qualification, and remediation activities for microbiology methods, aseptic technique, environmental monitoring, and documentation.\nModel strong quality mindset, scientific rigor, and compliance focused decision making.\nAdhere to all Edwards Environmental Health & Safety and Quality policies, including cleanroom and medical device manufacturing requirements.\nEnsure proper handling and disposal of microbiological, hazardous, and biohazardous materials in accordance with site and regulatory requirements.\nWhat you'll need (Required):\nBachelor's Degree in Microbiology or related field with significant industry experience, minimum 4 years’ experience in microbiology regulated laboratory environment or\nMaster's Degree in Microbiology or related field required, with minimum 2 years of progressive microbial experience or\nPhD in Microbiology or related field with minimum 1 year industry experience.\nWhat else we look for (Preferred):\nProven expertise in MS Office Suite\nExperience with aseptic techniques for bioburden and sterility tests, microbiological inoculums, assays, pipettes, identification and characterization, testing of medical devices, manufacturing processes, systems, and facilities, qualification involving sterilization processes, and environmental controls.\nExcellent written and verbal communication skills and interpersonal relationship skills\nDemonstrated problem-solving and critical thinking skills\nFull knowledge and understanding of Edwards policies and procedures relevant to microbiology\nFull knowledge and understanding of microbiology principles, theories and concepts\nAdvanced proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint\nExperience with laboratory equipment software (e.g. LIMS, WinKQCL, etc)\nExcellent written and verbal communications skills\nAdvanced problem-solving skills\nKnowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing\nStrict attention to detail\nKnowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment\nAbility to interact professionally with all organizational levels\nAbility to manage competing priorities in a fast paced environment\nAdhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.\nFor California, the base pay range for this position is $92,000 to $130,000 (highly experienced).\nThe pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.\nEdwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.","description_format":"text","description_chars":7928,"description_truncated":false,"requirements":{"experience_years_min":4,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Cardiovascular Devices","Patient Monitoring"],"lifecycle":[{"event":"open","at":"2026-09-24T00:43:04Z"},{"event":"close","at":"2026-10-19T11:08:31Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 45 · green card filings: 24","filings_12m":45,"filings_prev_12m":77,"green_card_filings_12m":24,"median_offered_wage_usd":125978,"route":null,"cap_exempt":false,"checked_at":"2026-10-15T11:24:14+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)","US Department of Labor: PERM disclosure data (green cards)"],"filings_for_role_12m":0}],"liveness":null,"pay":{"stated_usd_annual":130000,"is_top_pay":false},"html_url":"https://alion.io/job/edwards-lifesciences-senior-microbiologist","json_url":"https://alion.io/job/edwards-lifesciences-senior-microbiologist.json","meta":{"generated_at":"2026-10-27T04:14:15Z","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":3733,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-28T00:00:00Z"}},"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":5220},"rest":"https://alion.io/mcp/rest/get_company?id=5220"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fedwards-lifesciences-senior-microbiologist"},{"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%2Fedwards-lifesciences-senior-microbiologist"},{"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%2Fedwards-lifesciences-senior-microbiologist"},{"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/edwards-lifesciences-senior-microbiologist\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fedwards-lifesciences-senior-microbiologist"}]}