ph3CAI Overview: /h3pCAI 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. /ppOur approach is simple because our Purpose informs everything we do: /ppWe exist to be the trusted solution for our clients as they strive to build a better working world and improve the human experience. /ph3At CAI, we are committed to living our Foundational Principles, both professionally and personally: /h3pWe act with integrity /ppWe serve each other /ppWe serve society /ppWe work for our future /ppAt CAI, we believe in a relentless dedication to excellence, pushing boundaries and surpassing expectations. 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. /ppIt is absolutely necessary, in order to apply, to be a European citizen or to hold a valid residence permit for Europe. /ph3Key Responsibilities: /h3h31. Major Area 1 /h3pbThe 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. /b /ph3Position Requirements:



/h3pbBS in a Computer Science or Engineering field or equivalent experience /b /ppb2-7 years’ experience with Computer systems validation /b /ppb2 years’ experience working in a GMP environment /b /ppbaseptic process knowledge /b /ppbfilling line CSV and Automation experience /b /ppbExperience in Data Integrity with GAMP and 483, compliance, consent decree experience, deep 21CFR Part 11 experience is highly desired /b /ppbExperience in biotech and pharma is preferred over medical device /b /ppbExperience 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. /b /ph3Other Requirements: /h3pbExcellent oral and written communication skills in English/Fluent in English /b /ppbAble to travel domestically and internationally as required /b /ppbLa selezione rispetta il principio delle pari opportunità (l. 903/77) /b /ppCreates strategies to balance short-term requirements with long-range business plans. /ppPursues meaningful initiatives to capitalize on strengths, market opportunities, and counter competitive threats. /ppAligns strategic priorities of own area with current direction and strategic priorities of the broader organization. /ph3Apply Commercial Insights /h3pDemonstrates understanding of financial and economic levers that impact business performance and deploys them to improve short- and long-term results. /ppPromotes best-in-class risk awareness and reviews risk management performance on a continuing basis. /ppDraws appropriate conclusions from financial reports and analyses to identify and evaluate major strategic priorities and investments. /ph3Focus on Customers /h3pFosters a customer-focused environment. /ppIdentifies and anticipates customer requirements, expectations, and needs.



/ppCreates systems and processes that make it easy for customers to do business with CAI. /ph3Lead Execution /h3pMaintains accountability throughout the organization and encourages managed risk taking. /ppDelegates assignments to the lowest appropriate level and keeps people focused. /ppMonitors progress and redirects efforts when goals change or are not met. /ppEnsures people have resources, information, authority, empowerment, support needed to achieve objectives. /ph3Influence and Engage Others /h3pIdentifies the agendas, concerns, and motivations of others. /ppNegotiates persuasively to create win-win solutions for all parties. /ppCultivates networks across the organization to garner support and create a foundation for future influence. /ppInspires and coaches others to achieve beyond their own expectations and develop a winning mindset. /ph3Build Talent /h3pProvides feedback, coaching, and guidance where appropriate to enhance others’ skill development. /ppShapes roles and assignments in ways that leverage and develop people’s capabilities. /ppDevelops successors and talent pools to ensure availability of future talent. /ppPromotes the recruitment, advancement, and success of the best people from diverse backgrounds. /ph3Achieve Results with People /h3pFosters a sense of energy, ownership, and personal commitment to the work. /ppInspires others to stretch beyond what they thought they could do. /ppEncourages others to set challenging goals and high standards of performance. /ppCreates an environment in which performance excellence is rewarded. /ppChallenges self and others to learn and develop to improve capabilities. /ph3Lead Courageously and Safely /h3pDevelops and drives a safe and inclusive work culture. /ppTakes well-reasoned stands on important issues and always leads with integrity. /ppMakes tough people and business decisions and challenges the way it has always been done. /ppDevelops breakthrough ideas, safe working processes, initiatives, and business ventures. /ppDISPONIBILITA' A FARE TRASFERTE SIA ITALIA CHE ESTERO /ppLa selezione rispetta il principio delle pari occasione (l. 903/77) /p /p #J-18808-Ljbffr

📌 Computer System Validation Engineer (Milano)
🏢 Cagents
📍 Milano