h3CAI Overview: /h3 pCAI 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. /p h3Are You Ready? /h3 pCAI 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. /p pOur approach is simple because our Purpose informs everything we do: /p ul liWe exist to be the trusted solution for our clients as they strive to build a better working world and improve the human experience. /li /ul pAt CAI, we are committed to living our Foundational Principles, both professionally and personally: /p ul liWe act with integrity /li liWe serve each other /li liWe serve society /li liWe work for our future /li /ul pAt 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. /p pIt is absolutely necessary, in order to apply, to be a European citizen or to hold a valid residence permit for Europe. /p h3Key Responsibilities: /h3 pb1. Major Area 1 /b /p pbThe 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 /p h3Position Requirements: /h3 pbBS in a Computer Science or Engineering field or equivalent experience /b /p pb2-7 years’ experience with Computer systems validation /b /p pb2 years’ experience working in a GMP environment /b /p pbaseptic process knowledge /b /p pbfilling line CSV and Automation experience /b /p pbExperience in Data Integrity with GAMP and 483, compliance, consent decree experience, deep 21CFR Part 11 experience is highly desired /b /p pbExperience in biotech and pharma is preferred over medical device /b /p pbExperience 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 /p h3Other Requirements: /h3 pbExcellent oral and written communication skills in English/Fluent in English /b /p pbAble to travel domestically and internationally as required /b /p pbLa selezione rispetta il principio delle pari opportunità (l. 903/77) /b /p pCreates strategies to balance short-term requirements with long-range business plans. /p pPursues meaningful initiatives to capitalize on strengths, market opportunities, and counter competitive threats. /p pAligns strategic priorities of own area with current direction and strategic priorities of the broader organization. /p h3Apply Commercial Insights /h3 pDemonstrates understanding of financial and economic levers that impact business performance and deploys them to improve short- and long-term results. /p pPromotes best-in-class risk awareness and reviews risk management performance on a continuing basis. /p pDraws appropriate conclusions from financial reports and analyses to identify and evaluate major strategic priorities and investments. /p h3Focus on Customers /h3 pFosters a customer-focused environment. /p pIdentifies and anticipates customer requirements, expectations, and needs. /p pCreates systems and processes that make it easy for customers to do business with CAI.



/p h3Lead Execution /h3 pMaintains accountability throughout the organization and encourages managed risk taking. /p pDelegates assignments to the lowest appropriate level and keeps people focused. /p pMonitors progress and redirects efforts when goals change or are not met. /p pEnsures people have resources, information, authority, empowerment, support needed to achieve objectives. /p h3Influence and Engage Others /h3 pIdentifies the agendas, concerns, and motivations of others. /p pNegotiates persuasively to create win-win solutions for all parties. /p pCultivates networks across the organization to garner support and create a foundation for future influence. /p pInspires and coaches others to achieve beyond their own expectations and develop a winning mindset. /p h3Build Talent /h3 pProvides feedback, coaching, and guidance where appropriate to enhance others’ skill development. /p pShapes roles and assignments in ways that leverage and develop people’s capabilities. /p pDevelops successors and talent pools to ensure availability of future talent. /p pPromotes the recruitment, advancement, and success of the best people from diverse backgrounds. /p h3Achieve Results with People /h3 pFosters a sense of energy, ownership, and personal commitment to the work. /p pInspires others to stretch beyond what they thought they could do. /p pEncourages others to set challenging goals and high standards of performance. /p pCreates an environment in which performance excellence is rewarded. /p pChallenges self and others to learn and develop to improve capabilities. /p h3Lead Courageously and Safely /h3 ul liDevelops and drives a safe and inclusive work culture. /li /ul pTakes well-reasoned stands on important issues and always leads with integrity. /p pMakes tough people and business decisions and challenges 'the way it has always been done.' /p pDevelops breakthrough ideas, safe working processes, initiatives, and business ventures. /p pDISPONIBILITA' A FARE TRASFERTE SIA ITALIA CHE ESTERO /p pLa selezione rispetta il principio delle pari opportunità (l. 903/77) /p pLa selezione rispetta il principio delle pari occasione (l. 903/77) /p p€34,400 - €45,800 a year /p pThe compensation package offered ranges from €34,000 to €45,000 gross per annum (Gross Annual Salary). The final salary within this range will be determined according to the candidate’s technical competencies and relevant professional experience. /p #J-18808-Ljbffr

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