Key ResponsibilitiesMajor Area 1We are now seeking a Validation Engineer to join our growing operations in Italy. The Validation Engineer develops the documentation to support Commissioning, Qualifications, and Validation. These people are responsible for protocol writing and execution, field verification, and development of summary reports at the client site.The role of a Validation Engineer in CAI is to: Support documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment.Isolators qualification protocols execution and reporting, VHP cycle development, GMP based knowledgeResponsible for protocol writing and execution (field verification), and development of summary reports at client sites.Position RequirementsHigh attention to detailAbility to multi-task and take initiative to accomplish assigned tasks accurately by established BS or MS in a relevant science or engineering field, or equivalent years of hands-on experienceMinimum 3 – 5 years’ experience performing commissioning and / or qualification activities in an FDA regulated industry. Ideally, you will already have experience in facilities and equipment startup, walk downs & troubleshooting, utilities (WFI, RO, HVAC), building automation or other pharmaceutical manufacturing processes and equipment, FAT/SAT, URS, design review, P&IDs, IQ/OQ/PQs, generation & execution, etc.Provide cGMP leadership and guidance for the integration and delivery of VALIDATION services for our Life Sciences clients.Excellent technical problem-solving and troubleshooting skills, with solid knowledge of typical project technical issues deadlines.Ability to work independently, while quickly building and nurturing a project teamManaging the C&Q documentation and execution lifecycle from SLIA generation through to OQ completion.Support onsite and offsite activities, such as: FATs, SATs, IOQ and PQ Executions and System WalkdownsProficient in life science manufacturing processes in areas such as biotech, aseptic processing, aseptic fill/finish, OSD, Gene Therapy or equivalent experience.Familiarity with Baseline Guide 5 (Second Edition) a plusExpertise in Microsoft Word and ExcelExcellent oral and written English are required.Suitable candidates must be available for travel throughout Italy and some European travel may be required and a valid permit to stay for Italy.CAI OverviewAre 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:We exist to be the trusted solution for our clients as they strive to build a better working world and improve the human experience.At CAI, we are committed to living our Foundational Principles, both professionally and personally:We act with integrityWe serve each otherWe serve societyWe work for our futureAt 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 Apply Commercial InsightsDemonstrates 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 CustomersFosters 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.Lead ExecutionMaintains 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.Influence and Engage OthersIdentifies 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.Build TalentProvides 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.Achieve Results with PeopleFosters 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.Lead Courageously and SafelyDevelops 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.DISPONIBILITA' A FARE TRASFERTE SIA ITALIA CHE ESTEROLa selezione rispetta il principio delle pari opportunità (l. 903/77)
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