Computer System Validation Engineer M/W/D

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
Gehaltsspanne ab EUR 3.426,58 overpayment possible depending on experience and qualifications Wenn Sie sich in dieser Beschreibung wiederfinden und Interesse an einer abwechslungsreichen Tätigkeit haben, senden Sie Ihre aussagekräftigen Bewerbungsunterlagen mit Lebenslauf samt Foto an [email protected] z.H. Frau Melanie Berger, MA
Referenznummer:
00532102241120sds
Team 2 work Arbeitskräfteüberlassung GmbH
Rinnböckstraße 24/ Top 1
1110 Wien, Österreich
Tel +43 (0)1/892 1 892, Fax -14
E-Mail:
[email protected]