pMilano / ItalyEurope Life Sciences – South Europe /Full Time /HybridCAI Overview: Are You Ready? CAI 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. Our approach is simple because our Purpose informs everything we do: /p /brul /brliWe exist to be the trusted solution for our clients as they strive to build a better working world and improve the human experience. /li /br /ul /brpAt CAI, we are committed to living our Foundational Principles, both professionally and personally: /p /brul /brliWe act with integrity /li /brliWe serve each other /li /brliWe serve society /li /brliWe work for our future /li /br /ul /brpAt 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 /brpIt is absolutely necessary, in order to apply, to be a European citizen or to hold a valid residence permit for Europe. /p /brh3Key Responsibilities: /h3 /brol /brliMajor Area 1The 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. /li /br /ol /brh3Position Requirements:



/h3 /brul /brliBS in a Computer Science or Engineering field or equivalent experience /li /brli2-7 years’ experience with Computer systems validation /li /brli2 years’ experience working in a GMP environment aseptic process knowledge filling line CSV and Automation experienceExperience in Data Integrity with GAMP and 483, compliance, consent decree experience, deep 21CFR Part 11 experience is highly desiredExperience in biotech and pharma is preferred over medical deviceExperience 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. /li /br /ul /brh3Other Requirements: /h3 /brul /brliExcellent oral and written communication skills in English/Fluent in English /li /brliAble to travel domestically and internationally as required /li /brlila selezione rispetta il principio delle pari opportunità (l. 903/77) /li /br /ul /brpCreates strategies to balance short-term requirements with short-range business plans. Pursues meaningful initiatives to capitalize on strengths, market opportunities, and counter competitive threats. Aligns strategic priorities of own area with current direction and strategic priorities of the broader organization. Apply Commercial Insights Demonstrates understanding of financial and economic levers that impact business performance and deploys them to improve short- and long-term results. Promotes best-in-class risk awareness and reviews risk management performance on a continuing basis. Draws appropriate conclusions from financial reports and analyses to identify and evaluate major strategic priorities and investments. Focus on Customers Fosters a customer-focused environment. Identifies and anticipates customer requirements, expectations, and needs. Creates systems and processes that make it easy for customers to do business with CAI. /p /brh3Lead Execution /h3 /brpMaintains accountability throughout the organization and encourages managed risk taking. Delegates assignments to the lowest appropriate level and keeps people focused. Monitors progress and redirects efforts when goals change or are not met. Ensures people have resources, information, authority, empowerment, support needed to achieve objectives.



/p /brh3Influence and Engage Others /h3 /brpIdentifies the agendas, concerns, and motivations of others. Negotiates persuasively to create win-win solutions for all parties. Cultivates networks across the organization to garner support and create a foundation for future influence. Inspires and coaches others to achieve beyond their own expectations and develop a winning mindset. /p /brh3Build Talent /h3 /brpProvides feedback, coaching, and guidance where appropriate to enhance others’ skill development. Shapes roles and assignments in ways that leverage and develop people’s capabilities. Develops successors and talent pools to ensure availability of future talent. Promotes the recruitment, advancement, and success of the best people from diverse backgrounds. /p /brh3Achieve Results with People /h3 /brpFosters a sense of energy, ownership, and personal commitment to the work. Inspires others to stretch beyond what they thought they could do. Encourages others to set challenging goals and high standards of performance. Creates an environment in which performance excellence is rewarded. Challenges self and others to learn and develop to improve capabilities. /p /brh3Lead Courageously and Safely /h3 /brpDevelops and drives a safe and inclusive work culture. Takes well-reasoned stands on important issues and always leads with integrity. Makes tough people and business decisions and challenges the way it has always been done. Develops breakthrough ideas, safe working processes, initiatives, and business ventures. /p /brh3DISPONIBILITA' A FARE TRASFERTE SIA ITALIA CHE ESTEROL /h3 /brpla selezione rispetta il principio delle pari occasione (l. 903/77) /p /brp34,400 - 45,800 a year /p /brpThe 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 /brpWe may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us. /p #J-18808-Ljbffr

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