CSV Expert (Medical Device)

Barrington James; Stuttgart; Vor Ort; EUR 60.000 - 85.000; Vollzeit

Zusammenfassung

Barrington James is seeking a CSV / Computer System Validation Expert for a 2-year fixed-term assignment in Stuttgart, Germany. You will lead validation activities across IT environments, ensuring systems meet ISO 13485, EU MDR, and 21 CFR Part 11 standards, with emphasis on data integrity and risk-based testing.

The role requires hands-on CSV experience within medical devices, collaboration with Quality and IT teams, and ownership of validation documentation and requalification efforts to

Qualifikationen

• Experience in medical devices is desirable.
• Strong understanding of ISO 13485 and 21 CFR Part 11.
• Proficient in risk assessment, test plans and validation protocols.
• Experience with IT/infrastructure validation and data integrity.

Aufgaben

• Lead and execute CSV activities.
• Validate computerised systems, software, and processes.
• Create and maintain validation documentation.
• Develop risk assessments and test plans.
• Manage validated state of ERP systems.
• Support requalification and periodic reviews.
• Ensure compliance with regulatory requirements.
• Collaborate with Quality, IT and technical teams.

Kenntnisse

CSV expertise

Regulatory compliance

Data integrity

Quality mindset

Effective communication

Tools

ERP systems

Validation docs

Jobbeschreibung

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 activitiesEnsuring 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:

• Experience within Medical Devices is highly desirable
• 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