Senior Sterilization Engineer

Plymouth, Minnesota; Plymouth; Hybrid; USD 88,000 - 121,000; Full time

Job description

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 research we do and the products we develop improve outcomes for patients around the world. As a Sterilization Senior Engineer, Sterility Assurance at Vantive, your work supplies directly to making a significant impact on others. It's ambitious work—and you're not on your own. Our teams collaborate multi-functionally and lead by influence. Whether guiding a team through a project or leading direct reports, our research and development team is responsible for influencing others to achieve results.

Summary of Role:

This position will be responsible for the moist heat sterilization of medical devices for Vantive Kidney Care R&D division for North America. Activities include working with contract manufacturing plants and sterilization vendors to qualify the sterilization of Vantive's medical devices as well as providing domain expertise to support the sustaining of existing products.

• The role will have responsibility for the development and qualification of sterilization processes for pharmaceutical and medical device products.
• Provide recommendations 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 aligns with Vantive's Quality system and cGDP/cGMP practices.
• Provide regular updates to Sterility Assurance management.

What You’ll Do:

• Leading technical support groups through sterility assurance activities, such as planning and execution of qualifications.
• Applying, and where vital interpreting, sterilization standards to support the sterility assurance of Vantive products.
• Evaluating all aspects of sterility assurance for products being supported, including developing and driving qualification plans, and documenting results and conclusions.
• Devising innovative approaches to sophisticated problems through adaptations and modifications of standard technical principles.
• Assuring all work aligns with Vantive’s Quality system and cGDP/cGMP practices.
• Leading their own activities within larger projects and providing regular updates to the Vantive’s Kidney Care Sterility Assurance Management.

What You’ll Bring:

• Degree in Chemical Engineering, Mechanical Engineering, or related subject area.
• B.S. with greater than 4 years of related experience.
• or M.S. with greater than 2 years of related experience.
• Strong engineering background and experience.
• Experience in moist heat / steam sterilization.
• Strong statistical background. Able to apply statistical analysis to data sets to resolve 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.
• Minitab knowledge.
• Experience working in a manufacturing environment.

Vantive is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.

We understand compensation is an important factor as you consider the next step in your career. At Vantive, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $88,000 to $121,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

Equal Employment Opportunity

Vantive is an equal opportunity employer. Vantive evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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.