Vantive is a vital organ therapy company committed to extending lives and expanding possibilities for patients and care teams worldwide. With a legacy of 70 years in kidney care innovation, we are now enhancing the dialysis experience through digital solutions and advanced services, aiming for greater flexibility, efficiency, and longer, fuller lives for patients.
We are seeking a Validation Engineer to join our high-performing API manufacturing plant in Wavertree, Liverpool. The Validation Engineer will work closely with QA, Laboratory, Engineering, and Production teams to ensure validation processes are effectively completed and maintained in compliance with regulatory and Baxter corporate standards. This role reports to the Validation Manager and works Monday to Friday, 9 am to 5 pm, with some flexibility.
Key Responsibilities
1. Develop validation protocols for equipment, analytical methods, and CSV.
2. Collaborate on engineering projects to define validation requirements for new initiatives.
3. Serve as SME for computer systems integrity.
4. Act as a coach for validation activities.
5. Participate in site processes including Global Observation Certifications, Internal Audits, Investigations (NCR and CAPA), and implement validation improvements.
6. Manage quality system roles such as NCR/CAPA (trainer, initiator, owner), Change Control (owner), and Document Control (owner).
Qualifications and Experience
* Knowledge of validation techniques, including computer systems.
* Strong analytical skills and familiarity with data analysis tools and methodologies.
* Ability to collaborate across functions.
* Experience working within deadlines and regulatory standards.
Benefits of Working at Baxter
* Competitive compensation package
* Professional development opportunities
* Focus on work-life balance
* Commitment to diversity and inclusion
Additional Information
Vantive is dedicated to providing reasonable accommodations for individuals with disabilities during the application process. If needed, please click the link here to request accommodations.
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Additional Details
* Seniority level: Entry level
* Employment type: Full-time
* Job function: Quality Assurance
* Industry: Medical Equipment Manufacturing
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