Senior Specialist Computer System Validation Engineer m/w/d

Entreprise: team2work
Type d'emploi: Autre
We are currently looking for someone for our long-standing customer, a manufacturing pharmaceutical company Senior Specialist Computer System Validation Engineer m/w/d
  • 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 taking ownership on CSV

  • Degree in (Bio)Chemistry, Process Technology, Biotechnology, Pharmaceutical Technology, IT, Engineering or comparable work experience
  • 5+ years experience in Computer System Validation
  • 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

Wir bieten Arbeitszeit: 38h/Woche MO-Fr Flextime with possible home office option (max 40%)

Arbeitsort: 3500 Krems

Bruttomonatsgehalt: € 4.500,- with the willingness to overpay depending on experience and qualifications bis

A varied and challenging area of responsibility awaits you!