Computer System Validation Engineer m/w/d
Jobbeschreibung
Österreich
Mental Health Group
08.04.2024
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We are currently looking for someone for our long-standing customer, a manufacturing pharmaceutical company
- 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
- 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