Validation Analyst

Clario; Estenfeld (VGem); Hybrid; EUR 45.000 - 60.000; Vollzeit

Zusammenfassung

A healthcare technology company is looking for a Validation Analyst (f/m/x) at their Estenfeld site. This full-time role focuses on documentation and compliance for clinical data systems. The ideal candidate has a Bachelor's degree and experience in validation. The company offers a hybrid work environment, flexible hours, and extensive professional development opportunities.

Leistungen

Hybrid work environment (3 days in office, 2 days remote)

Flexible working hours

Support for professional development

On-site canteen

Competitive salary

Company pension scheme

Deutschlandticket for public transport

Free onsite parking

Social and wellness activities

Qualifikationen

• Minimum 1 year experience in a validation role or related job experience.
• Knowledge of GCPs, 21CFR Part 11 and related electronic record requirements desired.

Aufgaben

• Write concise documentation for validation of clinical data systems.
• Evaluate systems to determine necessary validation steps.
• Document and communicate deviations found during testing.
• Support Quality Assurance during client audits with documentation.

Kenntnisse

Organizational skills

Communication skills

Detail oriented

Proficiency in Microsoft Word

Proficiency in Microsoft Excel

Proficiency in PowerPoint

Ausbildung

Bachelor's Degree in Computer Science, Information Technology, Health/Life Sciences, Biomedical Engineering

Jobbeschreibung

We are looking for you as Validation Analyst (f/m/x) in full time (40h/week) at our Estenfeld (near Würzburg) site.

What We Offer

• Hybrid work environment (3 days in office, 2 days remote)
• Flexible working hours and working time accounts to support the work-life balance
• Support your professional development through internal and external training and certification programs
• Modern office building with an on-site canteen offering freshly cooked local dishes (with vegetarian option)
• Competitive Salary
• Company pension scheme
• The office in Estenfeld is well connected to the transport network. For public transport users, Clario offers the Deutschlandticket
• Free onsite parking
• We have both social and wellness committees that organize parties, events and activities

What You'll Be Doing

• Write concise and complete documentation to support the validation for internal clinical data systems or third party vendor systems. Documentation would include but is not limited to: Test Strategies, Test Reports, Test Summary Reports, Deviations and Traceability
• Evaluate new and updated systems or configurations to determine the necessary validation steps to assure compliance of those systems or configurations with industry standards and regulatory requirements
• Document and communicate deviations found during testing and maintain comprehensive tracking of all test deviations and associated corrective actions
• Interact with in-house development and operational staff in the development of system specifications and documentation
• Support Quality Assurance department with client audits by providing validation documentation, clarification of testing procedures or system demonstrations as needed
• Review results of test reports to ensure accurate and complete testing documentation
• Execute test reports to confirm system functionality is functioning as expected and meets the requirements of intended use
• Perform ongoing quality reviews of clinical data systems
• Coordinate with operational management in the identification, oversight, and training of end users in the execution of test scripts

What We Look For

• Bachelors Degree in Computer Science, Information Technology, Health/Life Sciences, Biomedical Engineering or relevant work experience
• Minimum 1 year experience in a validation role or related job experience
• Knowledge of GCPs, 21CFR Part 11 and related electronic record requirements desired
• Excellent organizational and communication skills
• Detail oriented
• Proficiency in Microsoft Word, Microsoft Excel, and PowerPoint

At Clario, our purpose is to transform lives by unlocking better evidence. It’s a cause that unites and inspires us. It’s why we come to work—and how we empower our people to make a positive impact every day. Whether you're advancing clinical science, building innovative technology, or supporting our global teams, your work helps bring life-changing therapies to patients faster.