Research Associate III - Sterility SME

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.

Research Associate III - Sterility SME

Principal Sterilization Engineer, Sterility Assurance (Moist Heat Sterilization)

This position will be responsible for the R&D activities related to moist heat sterilization of Vantive products at the Castlebar, Ireland facility. Activities include the assessment, protocol development, testing and reporting on moist heat sterilization cycle development and product testing. This position will work closely with the local Quality and Manufacturing teams moist heat sterilization studies, including preparing test samples, operation of equipment and collection/analysis of data. This position will support global projects and will need to work with multinational project teams to plan, conduct and report out on R&D sterilization activities. On occasion the position will coordinate the sample sterilization at third party contract testing laboratories.

Responsibilities of the role

• The role will have responsibility for the development and qualification of sterilization processes for pharmaceutical and medical device products.

• Provide input on the sterility assurance and microbial control for new product development as well as the sustaining of existing marketed products.

• Work with product development teams, product design owners, laboratory and manufacturing personnel to complete required tasks.

• Assure all work complies with Vantives’s Quality system and cGDP/cGMP practices.

• Provide regular updates to Sterility Assurance management.

• Leading project teams through sterility assurance activities, such as planning and execution of qualifications.

• Applying, and where necessary interpreting, sterilization standards to support the sterility assurance of Vantive products.

• Evaluating all aspects of sterility assurance for products being supported, including developing and executing qualification plans, and documenting results and conclusions.

• Devising new approaches to complex problems through adaptations and modifications of standard technical principles. 

• Assuring all work complies with Vantive’s Quality system and cGDP/cGMP practices.

• Managing their own activities within larger projects and providing regular updates to the Vantive’s Sterility Assurance Management.

Qualifications. The preferred candidate will have:

• Strong engineering background and experience.

• Understanding of the Science & Sterilization principles, guidance, regulations around sterilization validation & related to Sterility Assurance for Solutions.

• Experience in moist heat / steam sterilization.

• Strong statistical background. Able to apply statistical analysis to data sets to determine differences and similarities.

• Experience managing multiple simultaneous work activities

• Knowledge of medical device and/or pharmaceutical sterilization.

• Knowledge of GDP/GMP/GLP practices.

• Ability to convince management on courses of action, with some assistance, using both written and verbal methods. 

• Effectively operate in cross-functional teams with limited guidance. 

Desirable Skills

• Pharmaceutical or Medical Device manufacturing experience is desirable.

• Knowledge of other sterilization modalities such as radiation or ethylene oxide.

• Minitab knowledge

• Experience working in a manufacturing environment

• Degree in Chemical Engineering, Mechanical Engineering, or related discipline.

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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