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
Qualification
- 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
k.prilisauer@powerserv.at
