Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.As a Quality Engineer - Projects at Vantive Castlebar you will be responsible for managing aspects of quality for a wide range of projects including new product introduction and process improvements.Vantive Castlebar manufacture critical solutions and medication delivery that extends lives and expands possibilities.You will work and collaborate with colleagues across many functions including validation, engineering, product development, EHS and manufacturing.What you will be doing: Working within Validation/QA teams on the preparation and execution of protocols for facility, equipment, new product introductions, software and process validationLeading and participating on re-validation and process improvement initiativesPlan and execute protocol preparation in collaboration with Site Quality, Manufacturing processesProject manage the implantation of protocols to demonstrate validation of manufacturing processesResponsibility for preparation and sign-off of completed process validation documentsPrepare and secure validation strategy to regulatory agenciesParticipate in internal / external auditsEnsure manufacturing operations are maintaining product quality standardsCertify corrective action is taken to prevent reoccurrence of obstaclesAuthorise stop processes in the event of issuesSupport processing of product complaints and ensuring any corrective actions are taken to prevent reoccurrenceReview and approve process changes using a Change Management SystemAuthorise and approve the dispositioning of non-conforming productsParticipate in the generation, review and approval of risk management, control plans and pFMEA’s for new product introductionWe are looking for someone that has: 3rd level degree in Engineering, Science or ITMinimum of 2 years industrial experience in a QA role preferably in a pharmaceutical, healthcare or similar heavily regulated environmentExperience in process and equipment validationRisk assessment including FMEA techniquesGood level in understanding of control software and software development and implementationRegulatory audit/inspection experiencePractical experience of both EuGMP and FDA validation requirementsExperience in representing the validation function at regulatory inspectionsExperience in working closely with site engineering, manufacturing and quality functionsThe ability to work as part of a team to contribute to problem solving and deliver solutions in multi-disciplinary environmentAble to perform in a demanding high-volume environment and work to deadlines with high-value projectsStrong analytical and innovate approach to achieve outcomesExcellent verbal and written communication skillsReasonable AccommodationVantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form LinkRecruitment Fraud NoticeVantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.