Validation Analyst

Join Clario, part of Thermo Fisher Scientific, as Validation Analyst (f/m/d) at our Estenfeld (near Würzburg) site.

Be a part of driving clinical trials faster with your daily performance. You will be responsible for ensuring that our customers (pharma companies) can be confident that our test devices for our Precision Motion, Respiratory and Cardiac business lines are working as intended.

What We Offer

• Office work environment with 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)
• 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