CSV Expert (Medical Device)

CSV / Computer System Validation Expert | Medical Devices | 2-Year Fixed-Term Contract | Stuttgart, Germany

I’m currently supporting a growing medical device manufacturer within the ophthalmology space that is looking to bring in a CSV / Computer System Validation Expert on a 2-year fixed-term basis.

This is a great opportunity for someone with strong hands-on CSV experience who wants to take ownership of validation activities within a regulated medical device environment.

The Role

You’ll be responsible for supporting and strengthening the company’s computerised systems validation activities, with an upcoming internal project making this role particularly important from day one.

Your responsibilities will include:

• Leading and executing Computer System Validation (CSV) activities
• Validating computerised systems, software, equipment and processes
• Creating and maintaining validation and qualification documentation
• Developing risk assessments, test plans and validation protocols
• Managing the validated state of existing systems, including ERP systems
• Supporting requalification and periodic review activities
• Ensuring systems remain compliant with applicable regulatory requirements
• Helping develop and improve internal CSV processes and expertise
• Working closely with Quality, IT and technical teams

The ideal candidate will have:

• Hands-on CSV / Computer System Validation experience
• Experience within Medical Devices is highly desirable
• Experience validating ERP, IT or quality-relevant systems
• Understanding of IT infrastructure, servers, interfaces and computerised processes
• Knowledge of ISO 13485, EU MDR 2017/745 and 21 CFR Part 11
• Strong understanding of Data Integrity
• Experience with validation documentation, risk assessments, testing and requalification
• Strong communication skills across both Quality and IT/technical functions
• German B2 or above – essential
• Good English communication skills