{"id":4295657,"url":"https://alion.io/job/genentech-sr-quality-engineer-qev","title":"Sr Quality Engineer QEV","company":{"id":1757810,"name":"Genentech","domain":"gene.com","url":"https://alion.io/company/gene-com","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":84,"open_postings":43,"ghost_share":0,"stale_share":0.837,"repost_share":0,"time_to_fill_p50_days":16,"computed_at":"2026-11-15T07:52:55Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","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":["Oceanside, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":94000,"max":174600,"currency":"USD","period":"year","gross":null,"usd_annual":174600},"salary_estimate":null,"experience_years_min":4,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-11-13T00:00:00Z","employer_posted_date":"2026-11-13","last_verified_at":"2026-11-15T02:38:34Z","board_verified":true,"closed_at":null,"days_open":2,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":2},"description":"Are you ready to dive into a thrilling career opportunity where you can make a tangible impact on people's lives? The Sr. Quality Engineer (QEV) will be joining a collaborative team, where innovation, quality, and compliance are at the core of everything we do. In this role, you will oversee and guide the validation processes for critical systems, ensuring compliance and driving continuous improvement across a wide range of projects. This is a unique opportunity to leverage your expertise in quality engineering and working cross-functionally to resolve complex challenges.\nThe Opportunity:\nReview and approve a variety of end to end (Introduction, Maintain, and Retire) Validation Project Plans, Protocols (IQs, OQs, IOQs, PQs), Summary Reports, validation strategies, and other lifecycle documents for equipment, facilities, utilities, cleaning validation, process validation, or computerized systems.\nTrack Validation activities and ensure target timelines are met and/or issues are communicated / escalated effectively and consistently. \nOversee protocol execution, perform data review and manage deviation resolution.\nOversight and management of contract resources including: onboarding, training, work prioritization, budgeting, and execution as necessary.\nEvaluate and audit the current validated status of equipment, facilities, utilities, cleaning processes, manufacturing processes, and computerized systems. Make suggestions for strategic improvements as well as ensure systems are operating in compliance and validated state.\nPerform role of subject matter expert and assess change control and discrepancy events for validated systems. Review validation lifecycle documents for compliance with CFRs, corporate policies (PQS), and site procedures (SOPs). \nApply advanced theory, technical principles, expert judgment, and cross-functional expertise to independently address a broad range of complex problems.\nWho You Are:\nBachelor’s Degree in Engineering, Life Science field or equivalent with 8-11 years combined engineering/validation/quality assurance/project management experience in a federally regulated industry.\nMinimum of 4 years validation experience in the pharmaceutical/biotechnology industry. \nMinimum of 3 years hands-on experience with equipment / utility / cleaning / process data review and analysis in a batch manufacturing environment. \nHands-on experience commissioning/validating GMP equipment/utilities/processes preferred. \nSound knowledge and understanding of GMP guidelines and US/international regulations applicable to the pharmaceutical/biotechnology industry. \nSubject matter expertise in at least one (1) of the following areas: equipment/facilities/utilities qualification, cleaning validation, process validation, computerized systems validation.- Experience in performing and/or oversight of process validation activities including technical product transfer is a plus \nAbility to influence project team members, customers, Technology Validation, Manufacturing, Engineering, and MTS in order to successfully achieve compliance with Quality requirements.\nDays worked: M-F Days \nRelocation benefits are not available for this posting\nThe expected salary range for this position based on the primary location of California is $94,000 to $174,600. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.\nBenefits\nGenentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.\nIf you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.","description_format":"text","description_chars":4225,"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":true,"industries":["Biotechnology","Drug Discovery","Oncology Therapeutics","Neurology & CNS Therapeutics"],"lifecycle":[{"event":"open","at":"2026-11-14T01:05:34Z"}],"visa":[{"country":"US","licensed_sponsor":true,"adverts_offering_sponsorship_24m":0,"sanctioned_now":false,"evidence":"H-1B filings in 12 months: 188 · green card filings: 34","filings_12m":188,"filings_prev_12m":151,"green_card_filings_12m":34,"median_offered_wage_usd":150788,"route":null,"cap_exempt":false,"checked_at":"2026-11-15T09:21:55+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":{"score":63,"band":"ok","label":"Likely open","p_open":1,"p_active":0.632,"p_room":1,"age_days":2,"expected_fill_days":16,"reasons":["conf:5","stale_co","velocity","win:early","comp:brand"],"computed_at":"2026-11-15T07:52:55Z"},"pay":{"stated_usd_annual":174600,"is_top_pay":true},"html_url":"https://alion.io/job/genentech-sr-quality-engineer-qev","json_url":"https://alion.io/job/genentech-sr-quality-engineer-qev.json","meta":{"generated_at":"2026-11-15T13:58:33Z","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":4984,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-16T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.1,"usd":0.01,"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":1757810},"rest":"https://alion.io/mcp/rest/get_company?id=1757810"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fgenentech-sr-quality-engineer-qev"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"free","price":{"credits":0,"usd":0},"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%2Fgenentech-sr-quality-engineer-qev"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.1,"usd":0.01},"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%2Fgenentech-sr-quality-engineer-qev"},{"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/genentech-sr-quality-engineer-qev\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fgenentech-sr-quality-engineer-qev"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":4295657}},{"tool":"search_jobs","arguments":{"company":"gene.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":4295657},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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