Sterility assurance expert

1 day ago Be among the first 25 applicantsCompany OverviewCAI 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 futureWe believe in relentless dedication to excellence, pushing boundaries and surpassing expectations. From the beginning, we’ve challenged ourselves to do what others wouldn’t. 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.ResponsibilitiesMajor Area 1Creates strategies to balance short‑term requirements with long‑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.Applies commercial insights 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.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.Maintains 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.Identifies the agendas, concerns, and motivations of others and 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.Provides 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.Fosters 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.Develops 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.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 field.Understanding 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 language.Suitable 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).Additional InformationDISPONIBILITA' A FARE TRASFERTE SIA ITALIA CHE ESTEROLa selezione rispetta il principio delle pari opportunità (l. 903/77)We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. 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.Job DetailsSeniority level : Not ApplicableEmployment type : Full‑timeJob function : Accounting/Auditing and FinanceIndustries : Pharmaceutical ManufacturingReferrals increase your chances of interviewing at CAI by 2×Sign in to set job alerts for “Assurance Specialist” roles.Greater Rome Metropolitan Area 2 months agoGreater Rome Metropolitan Area 1 month agoGreater Rome Metropolitan Area 3 days agoWe’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.#J-18808-Ljbffr