Are you looking for new and exciting challenges? Do you want to play a key role in ensuring the quality and compliance of
software systems in a future-oriented healthcare environment?
Then join us as a

Validation/Test Specialist (m/f/d)

To expand our young, dynamic, and growing team, we are seeking passionate professionals who excel in executing
validation and testing activities, managing compliance documentation, and supporting the digitalization of regulated
internal processes.

ABX-CRO is an internationally operating contract research organization based in Dresden. We provide global services
in the manufacturing, testing, and approval of pharmaceuticals and diagnostics. Our Validation team is responsible for
maintaining compliance with standards such as ISO 9001, EU GMP Annex 11, and FDA 21 CFR Part 11, ensuring our software
systems meet the highest quality requirements.

Your Tasks & Responsibilities:

• Prepare and maintain validation documents (Validation Plans, IQ/OQ/PQ protocols, specs, test scripts/reports) per ISO 9001, EU GMP Annex 11, FDA 21 CFR Part 11

• Execute and document IQ, OQ, PQ for GxP-relevant software

• Conduct risk assessments for patient safety and data integrity

• Implement and review data integrity controls (audit trails, access rights, electronic records/signatures)

• Manage change control procedures with impact analysis and validation

• Perform vendor assessments for third-party software compliance

• Design and execute manual/automated tests (TestComplete, RapidAPI, Postman)

• Define and document test cases/plans based on requirements

• Use SQL for test design, data validation, and troubleshooting

• Maintain test management tools (Jira, Youtrack)

• Support user training and participate in internal training

• Assist in audits, periodic reviews, and continuous process improvements

About you

• Degree in Computer Science, Medical Engineering or a comparable discipline
• Solid understanding of GxP, CSV (Computer System Validation) and the regulatory landscape including Annex 11, 21 CFR Part 11, and ISO 9001
• Practical experience with IQ/OQ/PQ execution, documentation and qualification of software or IT systems in regulated environments
• Familiarity with data integrity principles and GAMP 5 methodology is an advantage
• Hands-on experience with testing tools such as TestComplete, Postman, RapidAPI or equivalent is a plus
• SQL knowledge for performing data verification, test automation support or exploratory testing
• Reliable documentation skills and familiarity with validation templates and SOP-driven environments
• Analytical and solution-oriented mindset; strong communication and organizational skills
• Fluent English is essential; German language skills are beneficial

Your Point of Contact

Veit Weber
Director Software Development & Information Technology