IT-Techniker (m/w/d) Pharma - Computer System Validation Engineer

3500 Krems an der Donau Vollzeit

Our client is an international company in pharma industry, located in Krems an der Donau.
We are searching for a Computer System Validation Engineer.

Key activities & 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
  • Work 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


  • Degree in (Bio)Chemistry, Process Technology, Biotechnology, Pharmaceutical Technology, IT, Engineering or comparable work experience
  • 2 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

We offer

  • Full-time position 38h
  • The chance to work for an international group

Der für diese Position vorgesehene Brutto-Mindestverdienst beträgt EUR 3110,60 pro Monat. Bei entsprechender Qualifikation oder Berufserfahrung ist eine Überzahlung möglich.

Ihr Job-Kontakt:
Powerserv Austria GmbH
Katrin Prilisauer
Favoritenstraße 80
1100 Wien
+43 664 80303 1112