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. **About Us: Vantive's Mission** At Vantive, we are deeply connected by our mission. Regardless of your role at Vantive, your work positively impacts people around the world. You will experience a sense of purpose across the organization, knowing our work improves outcomes for millions of patients. Vantive products and therapies are present in nearly every hospital worldwide, in clinics, and in homes. For over 85 years, we have pioneered significant medical innovations that transform healthcare. Together, we create an environment where we are happy, successful, and inspire one another. This is where you can do your best work. Join us at the intersection of saving and sustaining lives, where your purpose accelerates our mission. **Your Role at Vantive** **Primary Purpose of the Position:** * Responsible for developing, coordinating, executing, and reviewing Validation and Qualification protocols to comply with Vantive’s internal policies and national and international regulations. * Strengthen continuous improvement in manufacturing processes and critical service production within the plant. **What You Will Do at Vantive:** * Monitor compliance with local health regulations (COFEPRIS), NOM-241, regulations of countries where products are exported, international standards, ISO 9001, and corporate requirements. Also ensure compliance with risk management processes when applicable. * Comply with NOM 059 regarding computerized systems; apply GAMP guidelines, CFR 21 Part 11, and international standards focused on computerized system validation. * Ensure compliance with applicable regulations to maintain validation status. * Qualify equipment, critical systems, and software used in various company processes. * Develop cleaning protocols and perform process validation development and execution. * Comply with current Master Validation Plans. * Generate required documentation according to assigned qualification or validation activities. * Develop protocols and reports for assigned qualification and validation tasks. * Develop and keep updated procedures applicable to qualification and validation processes according to corporate standards and national and international legislation. * Prepare, follow up, and respond to internal and external audits, ensuring Good Manufacturing Practices. * Provide information and support for Continuous Process Verification. **What You Will Bring:** * Degree in Chemical Engineering, Industrial Chemistry, Pharmaceutical Engineering, or Pharmacy * 1 year of experience in validations, qualification of manufacturing equipment and critical systems, and process validation. * Knowledge of regulations related to the Pharmaceutical Industry * Intermediate to advanced English proficiency. **Knowledge:** * Familiarity with Local Health Regulations (COFEPRIS) and international standards ISO 9001 / 13485. * Computer skills (Office, Outlook). * Manufacturing, Good Manufacturing Practices. **Competencies:** * Communication. * Customer Focus. * Collaboration and Teamwork. * Critical Thinking and Problem Solving. * Handling Ambiguity. * Motivation and Development of Others. **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 **Recruitment Fraud Notice** Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.