Senior Specialist Computer System Validation Engineer -…

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Our client is one of the world's most successful pharmaceutical companies, which offers an extensive product range of prescription drugs, vaccines and veterinary medicines.
The focus lies on developing innovative, therapeutic solutions for some of the most serious diseases, thus helping to improve the health and quality of patients. The employees share the vision of developing optimal solutions for both, humans and animals.

We are currently seeking new talents to join the team at our customer's site in Krems an der Donau (Lower Austria near Vienna) to apply their skills as:

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
• 5 years + experience in Computer System Validation
• Execute complete Ownership of CSV (Senior) as well as having full knowledge about CSV in general
• Execute Project Management as part of this role
• Analytical thinking skills
• Strong organizational, analytical, and problem-solving skills
• Very good knowledge of MS-Office
• Strong troubleshooting skills with the ability to explain technical topics to non-technical stakeholders
• Fluency in written and spoken English and German

We offer:

• For this position we offer a minimum salary of circa € 5.500,- gross p.m (on a full-time basis) - as a median value, depending on your qualifications and work experience the actual salary can be higher and is subject of final negotions with our customer
• 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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