IT-Techniker (m/w/d) Pharma - Senior Computer System Validation Engineer
vor 1 Woche
3500 Krems an der Donau
Arbeitszeit
38 Std/Woche
Entgelt
ab 3909,67 €/Monat
Our client is an international company in pharma industry, located in Krems an der Donau. 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
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 statusInitiate 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
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
We offer Full-time position 38h
The chance to work for an international group
Der für diese Position vorgesehene Brutto-Mindestverdienst beträgt EUR 3909,67 pro Monat. Bei entsprechender Qualifikation oder Berufserfahrung ist eine Überzahlung möglich.
Ihr Job-Kontakt:
POWERSERV Austria GmbH
Katrin Prilisauer
Favoritenstraße 80
1100 Wien
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