{"id":2772514,"url":"https://alion.io/job/ust-architect-i-software-testing","title":"Architect I - Software Testing","company":{"id":1774626,"name":"UST","domain":"ust.com","url":"https://alion.io/company/ust-com","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"RippleHire","truth_index":{"grade":"B","score":75,"open_postings":114,"ghost_share":0,"stale_share":0.991,"repost_share":0,"time_to_fill_p50_days":30,"computed_at":"2026-11-01T06:10:25Z"}},"role":"QA","role_family":"QA","seniority":"staff","employment_type":null,"work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Pune, India"],"countries":["IN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":14500,"max_usd":33000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":214},"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false}],"status":"live","first_seen_at":"2026-09-03T00:00:00Z","employer_posted_date":"2026-10-17","last_verified_at":"2026-11-01T16:03:21Z","board_verified":true,"closed_at":null,"days_open":59,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":59},"description":"Who we are:\nAt UST, we help the world’s best organizations grow and succeed through transformation. Bringing together the right talent, tools, and ideas, we work with our client to co-create lasting change. Together, with over 30,000 employees in 30+ countries, we build for boundless impact-touching billions of lives in the process. Visit us at .\nUST is looking for CSV / CSA Lead (Computer System Validation & Computer Software Assurance Lead)\nExperience 10-15+ Years\nDomain Life Sciences / Pharma / Biotechnology / Medical Devices Location Global Delivery / Hybrid\nRole Summary The CSV / CSA Lead is responsible for leading validation and assurance activities for GxP-regulated computerized systems across laboratory, manufacturing, quality, and enterprise platforms. The role provides strategic and operational leadership for Computer System Validation (CSV), Computer Software Assurance (CSA), Data Integrity, Risk Management, and Regulatory Compliance initiatives. The individual will establish validation strategies, govern validation execution, guide CSA adoption, ensure inspection readiness, and partner with Quality, IT, Manufacturing, Laboratory Operations, and Regulatory stakeholders to deliver compliant and audit-defensible systems. Key Responsibilities CSV / CSA Strategy & Governance\nDefine and maintain CSV and CSA methodologies, procedures, templates, and governance frameworks.\nDrive adoption of risk-based CSA approaches and validation best practices.\nEstablish standardized validation processes across programs, sites, and business units.\nSupport development of Validation and CSA Centers of Excellence (CoE). Validation Lifecycle Leadership\nLead the complete validation lifecycle for computerized systems.\nDevelop and review:\nValidation Plans\nIQ, OQ, PQ\nValidation Summary Reports\nConduct and facilitate risk assessments and gap analyses.\nEnsure complete requirements traceability through testing, approvals, and deployment. Computer System Validation (CSV)\nGovern CSV lifecycle documentation including requirements, design, testing, defect management, and traceability.\nEnsure computerized systems comply with applicable regulations including FDA 21 CFR Part 11 and data integrity requirements.\nCollaborate with IT, QA, Quality Systems, Manufacturing, and Laboratory teams to validate GxP-relevant systems.\nServe as CSV subject matter expert during audits and inspections. Computer Software Assurance (CSA)\nApply CSA principles using intended use, critical thinking, and risk-based decision-making.\nDefine assurance strategies based on system impact and risk.\nImplement streamlined testing approaches while maintaining compliance.\nTrain project teams and stakeholders on CSA methodology and best practices. Regulatory Compliance & Inspection Readiness\nEnsure compliance with GxP, FDA 21 CFR Part 11 ,EU Annex 11, GAMP 5, ALCOA+ Data Integrity Principles\nPartner with Quality Assurance teams to support inspections and regulatory audits.\nSupport CAPA, deviation investigations, remediation activities, and inspection responses. Data Integrity Leadership\nAct as Data Integrity SME for regulated systems.\nEnsure appropriate implementation of Audit Trails, Electronic Signatures, User Access Controls, Traceability Controls, Data Lineage Requirements\nAssess and mitigate data integrity and compliance risks across system implementations. Stakeholder & Program Leadership\nWork closely with QA, IT and Business stakeholders\nLead validation planning and execution across multiple projects and global teams.\nProvide status updates, risk reporting, and compliance metrics to leadership stakeholders. Continuous Improvement & Automation\nIdentify opportunities to improve validation efficiency through automation and standardized processes.\nSupport validation tool implementation and process optimization initiatives.\nParticipate in digital transformation programs involving regulated systems. Required Qualifications Education\nBachelor's or Master's degree in:\nPharmacy\nLife Sciences\nBiotechnology\nEngineering\nComputer Science\nRelated discipline. Experience\n10-15+ years in Life Sciences and GxP-regulated environments.\nExperience leading CSV and CSA programs.\nProven experience supporting regulated computerized systems within pharmaceutical, biotechnology, or medical device organizations.\nExperience supporting regulatory inspections and audits. Technical Skills Validation & Compliance\nComputer System Validation (CSV)\nComputer Software Assurance (CSA)\nGAMP 5\nFDA 21 CFR Part 11\nEU Annex 11\nALCOA+\nRisk Assessments\nRequirements Traceability\nCAPA and Deviation Management\nData Integrity Programs. Platforms & Systems Experience validating one or more of:\nLIMS (LabWare, LabVantage, SampleManager)\nMES\nQMS Platforms (Veeva QMS, MasterControl, TrackWise)\nERP Systems\nELN\nCDS\nManufacturing and Laboratory Systems. Validation Tools Exposure to:\nValGenesis\nKneat\nHP ALM\nVeeva Validation Solutions and related validation toolsets. Leadership Competencies\nStrong compliance and quality mindset.\nAbility to interpret and apply regulatory guidance.\nCross-functional stakeholder management.\nRisk-based decision making.\nExecutive communication and presentation skills.\nTeam mentoring and capability development.\nContinuous improvement orientation. Preferred Qualifications\nExperience establishing or supporting a Validation / CSA CoE.\nExperience transitioning organizations from CSV-centric to CSA-aligned approaches.\nExperience supporting laboratory informatics, manufacturing execution, or digital transformation initiatives.\nParticipation in FDA, EMA, MHRA, or other health authority inspections.\nExperience with AI system validation or automated validation approaches.\nWhat we believe:\nWe’re proud to embrace the same values that have shaped UST since the beginning. Since day one, we’ve been building enduring relationships and a culture of integrity. And today, it's those same values that are inspiring us to encourage innovation from everyone, to champion diversity and inclusion and to place people at the centre of everything we do. \nHumility:\nWe will listen, learn, be empathetic and help selflessly in our interactions with everyone.\nHumanity:\nThrough business, we will better the lives of those less fortunate than ourselves.\nIntegrity:\nWe honour our commitments and act with responsibility in all our relationships.\n Equal Employment Opportunity Statement\nUST is an Equal Opportunity Employer. We believe that no one should be discriminated against because of their differences, such as age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation.\nAll employment decisions shall be made without regard to age, race, creed, colour, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.\nUSTreserves the right to periodically redefine your roles and responsibilities based on the requirements of the organization and/or your performance.\n\nTo support and promote the values of UST.\n\nComply with all Company policies and procedures","description_format":"text","description_chars":7183,"description_truncated":false,"requirements":{"experience_years_min":10,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[{"name":"India","iso":"IN","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","IT Consulting & Digital Transformation","IT Outsourcing & Dedicated Teams"],"lifecycle":[{"event":"open","at":"2026-10-17T06:49:13Z"}],"visa":[],"liveness":{"score":19,"band":"cold","label":"Long shot","p_open":1,"p_active":0.517,"p_room":0.36,"age_days":59,"expected_fill_days":30,"reasons":["conf:2","stale_co","velocity","win:tail","crowd:brand"],"computed_at":"2026-11-01T06:10:25Z"},"pay":null,"html_url":"https://alion.io/job/ust-architect-i-software-testing","json_url":"https://alion.io/job/ust-architect-i-software-testing.json","meta":{"generated_at":"2026-11-01T17:11:28Z","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":26321,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-02T00:00:00Z"}},"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":1774626},"rest":"https://alion.io/mcp/rest/get_company?id=1774626"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fust-architect-i-software-testing"},{"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%2Fust-architect-i-software-testing"},{"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%2Fust-architect-i-software-testing"},{"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/ust-architect-i-software-testing\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fust-architect-i-software-testing"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":2772514}},{"tool":"search_jobs","arguments":{"company":"ust.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":2772514},"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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