CSV Engineer - #2666543

Company Overview

Our client is a world-renowned manufacturer of high-quality ophthalmic medical devices, specialising in intraocular lenses. With a long-standing reputation for precision and innovation, they are a leader in their field.

As they continue to uphold the highest standards of quality and regulatory compliance, they are seeking a CSV Engineer to join their team in Stuttgart and play a crucial role in validating their computerised systems.

Key Responsibilities

You will be responsible for:

• Planning, executing, and documenting the validation of a wide range of computerised systems and software applications.
• Preparing and maintaining validation documentation, including validation plans, risk assessments, test protocols, and summary reports.
• Conducting risk assessments to evaluate software and equipment-related risks according to industry standards.
• Managing and monitoring the validation status of existing systems, with a particular focus on the company's ERP system.
• Preparing and maintaining qualification and validation documentation for manufacturing equipment, processes, and systems.
• Performing periodic requalification activities to ensure ongoing compliance.
• Acting as the internal subject matter expert for Computerised System Validation (CSV).
  
  

Candidate Profile

Essential Experience

• A strong background in Computerised System Validation (CSV) within a regulated industry.
• Practical experience in planning, executing, and documenting CSV activities.
• Experience validating ERP systems, IT infrastructure, and server environments.
• A thorough understanding of relevant regulatory requirements including ISO 13485, EU MDR (2017/745), and 21 CFR Part 11.
• Knowledge of IT systems, network infrastructures, and software-supported business processes.
• A solid understanding of data integrity principles and requirements.
  
  

Desirable Experience

• Experience working within the medical device industry.
• Direct experience with equipment and process qualification.
  
  

Why Join?

This Is An Opportunity To

• Take a key role in the quality and compliance function of a leading medical device manufacturer.
• Work with a variety of systems and technologies, from business ERPs to manufacturing equipment.
• Join a stable, respected company with a global reputation for excellence in the ophthalmic sector.
• Have a direct impact on product quality and patient safety by ensuring robust system compliance.
  
  

Package

• Base salary: c. €65,000
• Bonus: To be confirmed
• Benefits: To be confirmed
• Location: Stuttgart
• Travel requirements: To be confirmed
  
  

Apply

For a confidential discussion or to apply for this opportunity, please submit your CV.

Due to the volume of applications, only suitable candidates will be contacted.