Computer System Validation Engineer

Our client is one of the world's most successful pharmaceutical companies. The company offers an extensive product range of prescription drugs, vaccines and veterinary medicines. The company has succeeded in developing innovative, therapeutic solutions for some of the most serious diseases, thus helping to improve the health and quality of life of people affected. The employees share the vision of improving the health of people worldwide. They work with great dedication to further develop optimal solutions.

We are currently looking for a

Your responsibilities:

• Leading assigned Commissioning, Qualification and Validation (CQV) activities focusing on Computer System Validation (CSV).
• Sub-system owner (SSO) for CSV.
• Additionally support CQV activities for equipment, processes, and sterilizations.
• Development and approval of CQV Plans and Reports.
• Provide technical and CQV knowledge to equipment and systems owners including best practices and optimizations.
• Establish and/or participate in risk analysis and assessment to support CQV activities and change management
• Support Change Management, Deviation Management, and CAPA Management process on site and timely closure of tasks from the aforementioned
• Follow GMP, company, and local regulations regarding safety and CQV activities
• Works closely with IT, Automation, Quality, CQV, and Productions to ensure systems are compliant
• Support site CQV program by conducting periodic reviews, requalifications, Sanitization/Sterilization in Place (SIP) and Performance Qualifications (PQs), Commercial off-the-shelf (COTs), in addition to undertaking Subject Matter Expert responsibilities.
• Work in an interdependent team and with stakeholders to ensure facility and equipment maintains qualified and validated status
• Initiate and support continuous improvement activities within CQV and the site

Your qualifications and competences:

• Degree in (Bio)Chemistry, Process Technology, Biotechnology, Pharmaceutical Technology, IT, Engineering or comparable work experience
• 2 years experience in Computer System Validation
• Analytical thinking skills
• Very good knowledge of MS-Office
• Problem-solving skills
• Fluent in German and English (C1-level)

Offer:

• For this position we offer a minimum salary of 3.500 EUR gross p.m (full-time basis). Depending on your qualifications and work experience, the actual salary can be higher.
• Limited until Mai 2026
• Bonus scheme
• Team oriented and modern company culture
• Company canteen with discounted lunch menus
• International work environment and cooperation
• Attractive additional benefits

We are very much looking forward to receiving your application and we will be pleased to provide you further details upon request.

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