{"id":3773826,"url":"https://alion.io/job/avacone-group-eu-qualification-lead-itot","title":"Qualification Lead - IT/OT","company":{"id":669451,"name":"Avacone Group EU","domain":"avacone.eu","url":"https://alion.io/company/avacone","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workable","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"lead","employment_type":"contractor","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":null,"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 11","optional":false},{"name":"GMP","optional":false},{"name":"ServiceNow","optional":false},{"name":"Veeva","optional":false}],"status":"live","first_seen_at":"2026-11-04T22:30:55Z","employer_posted_date":"2026-11-04","last_verified_at":"2026-11-11T01:49:24Z","board_verified":true,"closed_at":null,"days_open":6,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":6},"description":"Qualification Lead Role:\n· Primary focus is to ensure that the qualification of the OT system, quality management for IT and OT systems, ensuring that the required validation / qualification deliverables are implemented according to the Customer Quality Manual and the relevant regulatory requirements\n· According to the Customer procedures, author, review and/or approve various validation / qualification deliverables\n· Review / approve validation / qualification deliverables as provided by the supplier of the relevant system(s), ensure that such deliverables are compliant to the Customer requirements\n· Lead the project test resources in relation to the validation / qualifications related activities of the project\n· Act as the project’s quality representative in relation to testing activities, engaging with local site QA and/or QA eCPL\n· Report on the status of the various quality-related activities for key stakeholders\n· Engagement with the suppliers to advise the suppliers on the suitable completion of supplier provisioned validation / qualification deliverables.\nRequired Validation Activities\nQualify IT/OT systems per Customer Quality Manual.\nAuthor, execute and review URS, FS, IQ, OQ and test protocols in Kneat.\nPerform test execution, troubleshooting and defect resolution.\nReview supplier deliverables and verify compliance.\nCoordinate with QA, PCM, ITOT teams and suppliers.\nParticipate in FAT, SAT, commissioning and startup activities.\nDesired Experience Profile\nThe candidate profiles proposed for this RFP emphasize:\nStrong CSV/CQV experience.\nGMP-regulated pharmaceutical manufacturing background.\nGAMP 5, EU GMP Annex 11, 21 CFR Part 11 knowledge.\nExperience with PLC, SCADA, DCS, MES, Historian, and IT/OT systems.\nHands-on IQ/OQ/PQ execution and FAT/SAT support.\nExperience using Kneat, ValGenesis, Veeva Vault, TrackWise, ServiceNow or similar validation platforms.","description_format":"text","description_chars":1899,"description_truncated":false,"requirements":{"experience_years_min":null,"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":["IT Consulting & Digital Transformation","Healthcare & Life Sciences Consulting"],"lifecycle":[{"event":"open","at":"2026-11-04T22:30:55Z"}],"visa":[],"liveness":{"score":90,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.903,"p_room":1,"age_days":5,"expected_fill_days":31,"reasons":["conf:2","velocity","win:early"],"computed_at":"2026-11-10T06:52:35Z"},"pay":null,"html_url":"https://alion.io/job/avacone-group-eu-qualification-lead-itot","json_url":"https://alion.io/job/avacone-group-eu-qualification-lead-itot.json","meta":{"generated_at":"2026-11-11T05:14:43Z","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":6623,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-12T00:00:00Z"}},"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":669451},"rest":"https://alion.io/mcp/rest/get_company?id=669451"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Favacone-group-eu-qualification-lead-itot"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":2,"usd":0.2},"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%2Favacone-group-eu-qualification-lead-itot"},{"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%2Favacone-group-eu-qualification-lead-itot"},{"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/avacone-group-eu-qualification-lead-itot\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Favacone-group-eu-qualification-lead-itot"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3773826}},{"tool":"search_jobs","arguments":{"company":"avacone.eu","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3773826},"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. Docs: https://alion.io/developers"}}