{"id":2869964,"url":"https://alion.io/job/lupin-qa-engineer-qae","title":"QA Engineer (QAE)","company":{"id":2071871,"name":"Lupin","domain":"lupin.com","url":"https://alion.io/company/lupin-com","size_band":"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":3,"ghost_share":0,"stale_share":0,"repost_share":0,"time_to_fill_p50_days":10,"computed_at":"2026-10-23T05:54:15Z"}},"role":"QA","role_family":"QA","seniority":"middle","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Somerset, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":67000,"max_usd":131000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":307},"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Windows","optional":false}],"status":"live","first_seen_at":"2026-10-19T19:13:00Z","employer_posted_date":"2026-10-19","last_verified_at":"2026-10-23T05:34:03Z","board_verified":true,"closed_at":null,"days_open":3,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":3},"description":"Shape the Future of Quality Systems and Compliance\nJob Description\nWe are seeking an experienced Quality Engineer-CSV to support the administration, validation, maintenance, and continuous improvement of computerized and electronic Quality Systems across laboratory, manufacturing, and Quality operations.\nAdminister and support PLCs, SCADA systems, Windows-based applications, laboratory instruments, manufacturing systems, and enterprise applications.\nSupport system administration activities including user/role management, security configuration, audit trails, backup/restore, reporting, and other system configurations.\nProvide end-user and operational support for Veeva Vault QMS, QualityDocs, Vault Training, and other quality systems.\nMaintain and improve electronic Quality Systems, including workflows, configurations, procedures, and system processes.\nDevelop and monitor Quality System metrics/KPIs, identify trends, and present results and improvement opportunities to management.\nIdentify opportunities to simplify, standardize, and improve the efficiency of Quality and computerized system processes.\nPerform CSV and data integrity activities including risk assessments, URS, configuration specifications, testing/UAT, RTM, validation reports, periodic reviews, and SOP updates.\nSupport qualification (Installation, Operational, and Performance Qualification) reviews of laboratory instruments and manufacturing equipment.\nPartner with Quality, IT, Engineering, vendors, and business users to troubleshoot issues and implement system enhancements.\nEnsure compliance with 21 CFR Part 11, 21 CFR Part 211, EU Annex 11, GAMP 5, Data Integrity.\nQualification and Experience\n Strong knowledge of GAMP 5, Annex 11, CSV, data integrity, and applicable FDA/EU requirements.\n Experience with Veeva Vault or similar electronic Quality Systems preferred.\n Strong analytical, troubleshooting, communication, and stakeholder-management skills.\n Hands on knowledge on Veeva, LIMS, ELN, SAP, and MES systems is preferred\n3-8 years of experience in Quality Systems, CSV, systems administration.\nExperience supporting laboratory, manufacturing, and/or enterprise computerized systems\nThe anticipated salary range for this position in New Jersey is $70,000 .00 to $90,000.00, plus discretionary 7.5% performance bonus (based upon eligibility). The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Lupin is a multi-state employer, and this salary range may not reflect positions that work in other states.\nLupin is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, gender, religion, age, disability, veteran’s status, or any other classification as required by applicable law.\nPhysical Requirements\nThe physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 15 pounds occasionally. Generally work is performed in an office environment.\nSearch Firm Representatives Please Read Carefully\nLupin USA, and its Affiliates does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms for any current openings at our company without a valid written search agreement in place will be deemed the sole property of Lupin. No fee will be paid in the event a candidate is hired by Lupin as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, No phone calls or emails\nCompetencies\nCollaboration\nCustomer Centricity\nDeveloping Talent\nInnovation & Creativity\nProcess Excellence\nResult Orientation\nStakeholder Management\nStrategic Agility","description_format":"text","description_chars":4178,"description_truncated":false,"requirements":{"experience_years_min":3,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Generic Drugs"],"lifecycle":[{"event":"open","at":"2026-10-19T19:13:00Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 2 · green card filings: 1","filings_12m":2,"filings_prev_12m":3,"green_card_filings_12m":1,"median_offered_wage_usd":94167,"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":{"score":82,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.822,"p_room":1,"age_days":3,"expected_fill_days":10,"reasons":["conf:0","win:early"],"computed_at":"2026-10-23T05:54:15Z"},"pay":null,"html_url":"https://alion.io/job/lupin-qa-engineer-qae","json_url":"https://alion.io/job/lupin-qa-engineer-qae.json","meta":{"generated_at":"2026-10-23T10:02:17Z","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":15253,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-24T00:00:00Z"}},"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":2071871},"rest":"https://alion.io/mcp/rest/get_company?id=2071871"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Flupin-qa-engineer-qae"},{"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%2Flupin-qa-engineer-qae"},{"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%2Flupin-qa-engineer-qae"},{"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/lupin-qa-engineer-qae\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Flupin-qa-engineer-qae"}]}