Sterility assurance expert

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 it will be done.Key Responsibilities1. Major Area 1Stiamo ricercando un profilo, per assunzione a tempo indeterminato, con le seguenti caratteristiche:Requested skillsLeads Sterility Assurance assessment in regulated manufacturing industry.Experience in Environmental qualification and Contamination control Strategy.Experience in aseptic process simulation risk assessment, validation strategy and oversight.Experience in Contamination control strategy of pharmaceutical sterile products.Execution of sterilizing equipment qualification.Experience in microbiological and biological method application and validation.Participates in cross functional projects, including customer meetings.Participates in the writing of protocols, reports, and specifications.Drives deliverables to completion with structured timelines.Requested QualificationsDegree in microbiology, biology, biotechnology or science‑related fieldUnderstanding of good documentation practices and general quality laboratory function.Ability to work independently and manage multiple projects simultaneously.Strong attention to details, organizational skills and drive to be successful.Experience with aseptic technique and biological safety cabinets.EssentialProficient in spoken and written English and /or a native languageSuitable candidates must be available for travel throughout Italy and some European travel may be required.La selezione rispetta il principio delle pari opportunità (l. 903/77)#LI-AG1Apply 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)#J-18808-Ljbffr