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.

The Sterilization Engineer II will support R&D activities related to moist heat sterilization of Vantive products at the Castlebar, Ireland facility. Under the guidance of Product Development & Engineering, activities include running moist heat sterilization cycle development, test article preparation and product testing. This position will work closely with the local Product Development, Engineering 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 the local Castlebar team to coordinate the work. On occasion the position may support sample sterilization at third party contract testing laboratories.

Description of Role:

The role will support the development and qualification of sterilization processes for pharmaceutical and medical device products.
Provide input on sterility assurance and microbial control for new product development as well as sustaining existing marketed products.
Liaise 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 global Sterility Assurance leadership

Responsibilities include:

Leading project teams through sterility assurance activities, such as planning and execution of sterilization cycle development and qualifications.
Applying, and where necessary interpreting, sterilization standards to support the sterility assurance of Vantive products.
Execute qualification plans, documenting results and conclusions.
Assuring all work complies with Vantive’s Quality system and cGDP/cGMP practices.
Work with the local ISC and R&D SMEs to support the testing and qualification of Vantive products.

Education and experience required:

Degree in Chemical Engineering, Mechanical Engineering, or related discipline.
B.S. with greater than 6 years of related experience. 
or M.S. with greater than 3 years of related experience. 
Engineering / Science / Steam Sterilization in manufacturing 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 and product sterility.
Strong understanding of moist steam vessel operation principles, understanding the parameters that impact product sterility requirements.
Experience working on multiple activities, simultaneously.
Knowledge of medical device and/or pharmaceutical sterilization.
Knowledge of GDP/GMP/GLP practices.
Strong organization skills with proven ability to manage and execute project tasks to strict project timelines.
Ability to provide updates to management using both written and verbal methods. 
Statistical background.
Effectively operate within 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

What Vantive can offer to you:

A permanent contract with 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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Sterilization Engineer II

Benefits

Job Description