Computer System Validation Expert (all gender)

About the Position

Computer System Validation Expert (all gender)

We are seeking a Computer System Validation Expert to join our team in Baden-Württemberg, ensuring compliance with GAMP5 and GxP requirements.

Responsibilities

• Plans, coordinates, and documents validation activities for computer-based systems and software solutions in accordance with GAMP5 and relevant GxP requirements.
• Contributes to the creation and maintenance of validation documents such as Risk Assessments, Test Plans, Test Cases, and Traceability Matrices.
• Ensures compliance with regulatory requirements (e.g., GMP, EU Annex 11, or FDA 21 CFR Part 11) throughout the lifecycle of systems and applications.
• Evaluates role and permission concepts as well as security-relevant functions in the context of system implementations and changes.
• Supports audits, inspections, and regular compliance reviews and serves as a contact person for validation questions.

Requirements

• Completed degree in Computer Science, Biomedical Engineering, Pharmacy, or a comparable qualification.
• Relevant experience in the validation of software or IT systems in a regulated environment.
• Proficiency in regulatory requirements such as GAMP5, EU Annex 11, and FDA 21 CFR Part 11.
• Experience in a risk-based approach to validation and in the creation and maintenance of validation documentation.
• Fluency in German and English, both written and spoken.

We Offer

• Talent Management – We develop your career.
• Work Life Balance – Flexible working hours and remote work options.
• Fit and relaxed – with EGYM Wellpass.
• Enjoy biking – Always on tour with company bike leasing.
• Green Mobility – Travel with us at a discount.
• IT Communities – Knowledge exchange, development, and networking with colleagues.

Additionally, we offer an indefinite employment contract, corporate benefits, and team events.

About the Company

Wir sind die Gestalter von heute für die Welt von morgen.

As one of the world's leading development service providers, we at ALTEN are committed to positively shaping the future of our partner companies, the careers of our employees, and the challenges for our society and environment.

Almost 60,000 employees in 30 countries are already working on innovative solutions in various engineering and IT sectors such as aerospace, renewable energies, medical technology, railway technology, and automotive.

We value diversity and welcome all applications – regardless of gender, nationality, ethnic and social origin, religion/belief, disability, age, or sexual orientation and identity.

Disabled individuals will be given preference in case of equal suitability.

Apply now through our online application form.

Apply Now

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