CSV Engineer

medtechrec; Stuttgart; Vor Ort; EUR 55.250 - 74.750; Vollzeit

Benefits dieser Stelle

Base salary: €65,000

Bonus: To be confirmed

Benefits: To be confirmed

Zusammenfassung

medtechrec in Stuttgart seeks a CSV Engineer to validate computerised systems within a regulated medical device environment. The role focuses on planning, executing, and documenting CSV activities across ERP systems, IT infrastructure, and manufacturing environments to ensure data integrity and regulatory compliance.

You'll prepare validation documentation, risk assessments, and qualification reports, acting as the internal CSV SME and contributing to product quality and patient safety through

Qualifikationen

• Experience in planning, executing, and documenting CSV activities.
• Experience validating ERP systems, IT infrastructure and server environments.
• Understanding ISO 13485, EU MDR 2017/745, and 21 CFR Part 11.
• Knowledge of data integrity principles and requirements.

Aufgaben

• Plan, execute, and document CSV validations across systems.
• Prepare validation plans, risk assessments, and test protocols.
• Assess risks of software and equipment related to CSV.
• Monitor validation status of systems including ERP.
• Prepare qualification/validation docs for manufacturing equipment and processes.
• Perform periodic requalification to maintain compliance.
• Act as internal CSV subject matter expert.

Kenntnisse

CSV validation

ERP validation

IT infrastructure

Data integrity

Jobbeschreibung

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

• 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