Computer System Validation Engineer - Pharma (m/f/d)
Globe Personal Services
- Krems An Der Donau, Niederösterreich
- € 3.500 pro Monat
- Unbefristet
- Vollzeit
- 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
- Degree in (Bio)Chemistry, Process Technology, Biotechnology, Pharmaceutical Technology, IT, Engineering or comparable work experience
- 2 years experience in Computer System Validation
- Analytical thinking skills
- Very good knowledge of MS-Office
- Problem-solving skills
- Fluent in German and English (C1-level)
- For this position we offer a minimum salary of 3.500 EUR gross p.m (full-time basis). Depending on your qualifications and work experience, the actual salary can be higher.
- Limited until Mai 2026
- Bonus scheme
- Team oriented and modern company culture
- Company canteen with discounted lunch menus
- International work environment and cooperation
- Attractive additional benefits
Mag. Claudia Geyerhofer
Walcherstraße 2A -Stock 10, Top 2 in 1020 Wien
M: +43 (0) 1 - 713 02 77 - 76
www.globe.at
Karriere.at