{"id":1656053,"url":"https://alion.io/job/ecolab-quality-engineer-software-process-validation","title":"Quality Engineer - Software & Process Validation","company":{"id":1754712,"name":"Ecolab","domain":"ecolab.com","url":"https://alion.io/company/ecolab-com","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":75,"open_postings":110,"ghost_share":0,"stale_share":0.991,"repost_share":0,"time_to_fill_p50_days":22,"computed_at":"2026-10-02T05:45:00Z"}},"role":"QA","role_family":"QA","seniority":"middle","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Buenos Aires, Argentina"],"countries":["AR"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-10-01T00:00:00Z","employer_posted_date":"2026-10-01","last_verified_at":"2026-10-02T16:02:44Z","board_verified":true,"closed_at":null,"days_open":2,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":2},"description":"Role Summary\nThe Software and Process Validation engineer is responsible for ensuring that computerized systems, manufacturing processes, equipment, utilities, facilities, and associated quality systems consistently perform as intended and comply with regulatory, quality, and business requirements. This role supports the full validation lifecycle, including planning, risk assessment, qualification, testing, documentation, change management, and maintenance of the validated state.\nKey Responsibilities\nLead software validation for new systems and changes, including requirements, risk assessments, testing, traceability, deviations, reports, integrations, and data migrations.\nSupport audits, inspections, and quality investigations\nPerform validation risk assessment utilizing the appropriate risk-validation and CSA principles \nEvaluate data integrity, access controls, audit trails, electronic records and signatures, security, backup and recovery, and continued validated-state requirements.\nSupport process and equipment validation, including IQ/OQ/PQ, PPQ, cleaning, utilities, facilities, technology transfer, and new product introduction.\nApply change control, CAPA, deviation, document-control, and risk-management requirements; monitor milestones, escalate risks, and support audits and inspections.\nLead validation of GxP computerized systems.\nDevelop and execute validation plans.\nCreate and review: URS, risk assessments; traceability matrices; test scripts and validation reports. \nAssess data integrity controls, audit trails, electronic records, and electronic signatures.\nSupport software implementations, upgrades, integrations, cloud applications, and system changes.\nRequired Qualifications\nBachelor's degree in Engineering, Computer Science, Information Systems, Life Sciences, Quality, or a related technical field.\nAt least 3 years of validation, quality engineering, quality systems, software quality, or related experience in a regulated environment.\nHands-on computerized system validation experience covering requirements, risk assessment, testing, traceability, deviations, and validation reporting.\nWorking knowledge of GxP/cGMP, FDA, ISO, data integrity, change control, CAPA, technical writing, and project execution.\nPreferred Qualifications\nExperience validating enterprise eQMS, laboratory, manufacturing, ERP, cloud/SaaS, reporting, integration, or data-migration solutions.\nExperience with process/product validation, equipment, facilities and utilities qualification, cleaning validation.\nKnowledge of ISO 9001, cGMP, FDA 21 CFR Parts 11, 210, 211, 820, Health Canada, ICH, Pic/s guidance, MHRA Data integrity \nMultilingual communication capability, preferably English plus Spanish or Portuguese, and willingness to travel to manufacturing locations","description_format":"text","description_chars":2790,"description_truncated":false,"requirements":{"experience_years_min":3,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"All levels","optional":true}]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Water Utilities","Chemical Manufacturing","Sterilization & Infection Control"],"lifecycle":[{"event":"open","at":"2026-10-02T01:44:30Z"}],"liveness":{"score":63,"band":"ok","label":"Likely open","p_open":1,"p_active":0.632,"p_room":1,"age_days":1,"expected_fill_days":22,"reasons":["conf:4","stale_co","velocity","win:early","comp:brand"],"computed_at":"2026-10-02T05:45:00Z"},"pay":null,"html_url":"https://alion.io/job/ecolab-quality-engineer-software-process-validation","json_url":"https://alion.io/job/ecolab-quality-engineer-software-process-validation.json","meta":{"generated_at":"2026-10-03T01:21:03Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","usage":{"tier":"crawler","counted_by":"address","units_charged":1,"used_today":1291,"day_limit":5000,"remaining_today":3709,"minute_limit":60,"resets_at":"2026-10-04T00:00:00Z"}}}