We are currently looking for someone for our long-standing customer, a manufacturing pharmaceutical company

Computer System Validation Engineer m/w/d

Ihre Aufgaben umfassen im Einzelnen:

• Additionally support CQV activities for equipment, processes, and sterilizations.
• Leading assigned Commissioning, Qualification and Validation (CQV) activities focusing on Computer System Validation (CSV)
• Sub-system owner (SSO) for CSV.
• 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

Ihr Profil

• 2 years experience in Computer System Validation
• Degree in (Bio)Chemistry, Process Technology, Biotechnology, Pharmaceutical Technology, IT, Engineering or comparable work experience
• Strong organizational, analytical, and problem-solving skills
• Strong troubleshooting skills with the ability to explain technical to non-technical stakeholders
• Fluency in written and spoken German and English
• Very good knowledge of MS-Office applications

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