IT-Techniker (m/w/d) Pharma - Computer System Validation Engineer

IT-TECHNIKER (M/W/D) PHARMA - COMPUTER SYSTEM VALIDATION ENGINEER

Einsatzort

3500 Krems an der Donau

Arbeitszeit

38 Std/Woche

Entgelt

3110.6 €/Monat

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 3110.6 €/Monat

Ihr Job-Kontakt:

Powerserv Austria GmbH

Katrin Prilisauer

Favoritenstraße 80

1100 Wien

+43 664 80303 1112

apply.job.21183244@hokifyjob.com