{"id":2094825,"url":"https://alion.io/job/cai-computer-system-validation-engineer","title":"Computer System Validation Engineer","company":{"id":3866618,"name":"CAI","domain":"caiready.com","url":"https://alion.io/company/caiready","size_band":"501-1000","is_staffing_agency":false,"employer_type":"staffing","is_intermediary":false,"listed_via":null,"ats_vendor":"Lever","truth_index":{"grade":"D","score":53,"open_postings":81,"ghost_share":0.79,"stale_share":0,"repost_share":0,"time_to_fill_p50_days":null,"computed_at":"2026-10-10T05:45:15Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"junior","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Milan, Italy"],"countries":["IT"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":34400,"max":45800,"currency":"EUR","period":"year","gross":null,"usd_annual":51294},"salary_estimate":null,"experience_years_min":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-09-16T08:50:35Z","employer_posted_date":"2026-09-16","last_verified_at":"2026-10-11T17:27:31Z","board_verified":true,"closed_at":null,"days_open":25,"trust":{"level":"ok","repost_count":0,"flags":["company_stale"],"days_open":24},"description":"CAI Overview:\nAre You Ready?\nCAI is a professional services company established in 1996 that has grown year over year to nearly 800 people worldwide. For Life Sciences and Mission Critical industries that need to deliver critical solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard through our rigorous approach, field tested processes, and elite expertise developed over 30 years.\nOur approach is simple because our Purpose informs everything we do:\n· We exist to be the trusted solution for our clients as they strive to build a better working world and improve the human experience.\nAt CAI, we are committed to living our Foundational Principles, both professionally and personally:\n· We act with integrity\n· We serve each other\n· We serve society\n· We work for our future\nAt CAI, we believe in a relentless dedication to excellence, pushing boundaries and surpassing\nexpectations. From the beginning, we’ve challenged ourselves to do what others wouldn’t. Not just setting industry standards, but redefining them entirely. We are bold in our thinking and creative in our approach. We operate at the intersection of wisdom and technology and thrive when they come together with humanity. For us, operational readiness isn’t simply a goal. It’s a way of life. Because tomorrow demands to be at the forefront of today. We do this through tireless effort, precision, efficiency and an unwavering belief that there is always room for advancement. We’re not interested in how it used to be done. We’re obsessed with how it will be done.\nIt is absolutely necessary, in order to apply, to be a European citizen or to hold a valid residence permit for Europe.\nKey Responsibilities:\n1.Major Area 1\nThe Computer Systems Validation (CSV) Engineer will develop and execute protocols and test scripts, identify gaps, and consult on and direct plans for resolution. This person is responsible for writing GxP computer validation and 21 CFR Part 11 related documentation such as assessments, plans, URS, FRS, RTM, and summary reports.\nPosition Requirements:\nBS in a Computer Science or Engineering field or equivalent experience\n2-7 years’ experience with Computer systems validation\n2 years’ experience working in a GMP environment\naseptic process knowledge\nfilling line CSV and Automation experience\nExperience in Data Integrity with GAMP and 483, compliance, consent decree experience, deep 21CFR Part 11 experience is highly desired\nExperience in biotech and pharma is preferred over medical device\nExperience with MES, Delta V, PI is a plus. We use all major systems as we serve a multitude of clients. Rockwell, GE, Emerson, ABB, Werum, Siemens, Honeywell and their associated platforms, PAS-X, Syncade, FactoryTalk, PharmaSuite, Control Logix, PLM, Simatic, iFix, Wonderware, Siemens, etc.\nOther Requirements:\nExcellent oral and written communication skills in English/Fluent in English\nAble to travel domestically and internationally as required\nLa selezione rispetta il principio delle pari opportunità (l. 903/77)\nCreates strategies to balance short-term requirements with long-range business plans.\nPursues meaningful initiatives to capitalize on strengths, market opportunities, and counter competitive threats.\nAligns strategic priorities of own area with current direction and strategic priorities of the broader organization.\nApply Commercial Insights\nDemonstrates understanding of financial and economic levers that impact business performance and deploys them to improve short- and long-term results.\nPromotes best-in-class risk awareness and reviews risk management performance on a continuing basis.\nDraws appropriate conclusions from financial reports and analyses to identify and evaluate major strategic priorities and investments.\nFocus on Customers\nFosters a customer-focused environment.\nIdentifies and anticipates customer requirements, expectations, and needs.\nCreates systems and processes that make it easy for customers to do business with CAI.\nLead Execution\nMaintains accountability throughout the organization and encourages managed risk taking.\nDelegates assignments to the lowest appropriate level and keeps people focused.\nMonitors progress and redirects efforts when goals change or are not met.\nEnsures people have resources, information, authority, empowerment, & support needed to achieve objectives.\nInfluence and Engage Others\nIdentifies the agendas, concerns, and motivations of others.\nNegotiates persuasively to create win-win solutions for all parties.\nCultivates networks across the organization to garner support and create a foundation for future influence.\nInspires and coaches others to achieve beyond their own expectations and develop a winning mindset.\nBuild Talent\nProvides feedback, coaching, and guidance where appropriate to enhance others’ skill development.\nShapes roles and assignments in ways that leverage and develop people’s capabilities.\nDevelops successors and talent pools to ensure availability of future talent.\nPromotes the recruitment, advancement, and success of the best people from diverse backgrounds.\nAchieve Results with People\nFosters a sense of energy, ownership, and personal commitment to the work.\nInspires others to stretch beyond what they thought they could do.\nEncourages others to set challenging goals and high standards of performance.\nCreates an environment in which performance excellence is rewarded.\nChallenges self and others to learn and develop to improve capabilities.\nLead Courageously and Safely\n· Develops and drives a safe and inclusive work culture.\nTakes well-reasoned stands on important issues and always leads with integrity.\nMakes tough people and business decisions and challenges “the way it has always been done.”\nDevelops breakthrough ideas, safe working processes, initiatives, and business ventures.\nDISPONIBILITA' A FARE TRASFERTE SIA ITALIA CHE ESTERO\nLa selezione rispetta il principio delle pari opportunità (l. 903/77)","description_format":"text","description_chars":6010,"description_truncated":false,"requirements":{"experience_years_min":2,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"Advanced (C1)","optional":false}]},"benefits":[],"hiring_locations":[{"name":"Italy","iso":"IT","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Professional Services","Science & 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