Validation Specialist

Responsibilities

• Conduct and manage validation activities to ensure equipment, processes, and computerized systems remain in a validated state.
• Draft validation protocols and reports (IQ/OQ/PQ) for processes, equipment, utilities, and computerized systems in compliance with applicable regulations.
• Perform validation activities within a production environment and conduct statistical data analysis.
• Collaborate on new installation projects and work effectively within multifunctional teams.
• Manage CAPA, Preventive Actions (PA), and non-conformities related to the validation department.
• Periodically reassess the validation status of processes and equipment.

Requirements

• University degree in Engineering, Pharmacy, Biology, or a related field.
• Proficiency in Microsoft Office applications.
• Fluency in written and spoken English.
• Basic knowledge of statistical methods.
• Strong interpersonal, organizational, and team-building skills.

Preferred Qualifications

• Previous experience in a pharmaceutical environment.
• Prior experience specifically in validation roles.

About the Company

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, and we are continuing to invest in transforming vital organ therapies through digital solutions and advanced services.