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.
Project Validation Engineer
Within this role, the Project Validation Engineer within the Engineering Projects team to ensure that validations are executed as per the Vantive QMS requirements.
Your role at Vantive:
* Writing validation protocols associated with equipment, analytical methods and CSV in line with Vantive QMS and regulatory expectations
* Working with engineering projects and site validation to scope out the validation requirements of new project
* Act as a coach for validation activities.
* Working alongside the Project validation manager to create and execute all elements of the projects VMP
* Partaking in the site processes for:
* Global Observation Certifications
* Internal Audit program
* Investigations inc. NCR and CAPA
* Implement leading validation indicators and continuous improvement of the validation process.
* Undertake the following quality system roles (including access to the relevant system):
NCR/CAPA: trainer, Initiator, owner
Change control: Owner
Document: owner
Qualifications:
* Knowledge and application of validation techniques, including computer systems.
* Applies analytical skills and knowledge of data analysis tools and methodologies.
* Cross functional collaboration.
* Working within set deadlines for projects and to required regulatory standards.
Reasonable Accommodation
Vantive 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 Link
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