Quality Projects Engineer

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 extend lives and expand 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 validation
• Leading and participating on re-validation and process improvement initiatives
• Plan and execute protocol preparation in collaboration with Site Quality, Manufacturing processes
• Project manage the implantation of protocols to demonstrate validation of manufacturing processes
• Responsibility for preparation and sign-off of completed process validation documents
• Prepare and secure validation strategy to regulatory agencies
• Participate in internal / external audits
• Ensure manufacturing operations are maintaining product quality standards
• Certify corrective action is taken to prevent reoccurrence of obstacles
• Authorise stop processes in the event of issues
• Support processing of product complaints and ensuring any corrective actions are taken to prevent reoccurrence
• Review and approve process changes using a Change Management System
• Authorise and approve the dispositioning of non-conforming products
• Participate in the generation, review and approval of risk management, control plans and pFMEA’s for new product introduction

We are looking for someone that has:

• 3rd level degree in Engineering, Science or IT
• Minimum of 2 years industrial experience in a QA role preferably in a pharmaceutical, healthcare or similar heavily regulated environment
• Experience in process and equipment validation
• Risk assessment including FMEA techniques
• Good level in understanding of control software and software development and implementation
• Regulatory audit/inspection experience
• Practical experience of both EuGMP and FDA validation requirements
• Experience in representing the validation function at regulatory inspections
• Experience in working closely with site engineering, manufacturing and quality functions
• The ability to work as part of a team to contribute to problem solving and deliver solutions in multi-disciplinary environment
• Able to perform in a demanding high-volume environment and work to deadlines with high-value projects
• Strong analytical and innovate approach to achieve outcomes
• Excellent verbal and written communication skills

What can Vantive offer to you:

• A stable and secure work environment
• A comprehensive benefits package, including private medical insurance, company pension scheme, and annual bonus scheme
• A collaborative and dynamic work environment
• Access to state-of-the-art equipment and technology
• Recognition and reward for outstanding performance

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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