R&D Engineer – Qualification & Validation

Responsibilities

• Plan and execute DQ, IQ, OQ, and PQ for laboratory and testing equipment throughout its lifecycle
• Develop, validate, and document analytical methods in accordance with regulatory and internal requirements
• Ensure compliance of computer-aided analytical software through CSV (Computer Software Validation), including risk analysis and testing strategies
• Initiate, evaluate, and implement changes to equipment, methods, and software, including impact assessments
• Support equipment lifecycle management, including calibration, maintenance, and documentation
• Create, instruct, and review validation documents, SOPs, and risk analyses
• Provide proactive support during audits and inspections
• Coordinate closely with Quality Assurance and local/international R&D teams

Requirements

• Degree in Medical Technology, Process Engineering, Pharmaceutical Technology, or a comparable field
• Several years of experience working in a regulated environment (MedTech, Pharma, or Diagnostics)
• Deep expertise in at least two of the following: Equipment Qualification (DQ/IQ/OQ/PQ), Method Validation, or CSV/Software Validation
• Strong knowledge of Change Management processes
• Proficiency with relevant regulations including ISO 13485, GMP, GAMP5, and ALCOA+
• Structured, precise, and independent working style
• Strong communication skills and professional presence, particularly in audit contexts
• Fluency in both German and English

Benefits

• Opportunity to work in an internationally networked R&D environment
• High level of responsibility in quality-critical processes
• Ability to actively shape and influence standards and processes
• A collegial environment with high technical expertise and professional growth potential

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. With a 70-year legacy in kidney care, we are advancing digital solutions and innovative therapies to improve the lives of patients worldwide.