Validation and Qualification Engineer (m/f/d)
Merck & Co.
- Krems An Der Donau, Niederösterreich
- € 43.548 pro Jahr
- Unbefristet
- Vollzeit
Validation and Qualification Engineer (m/f/d)
Full-time, as soon as possibleValidation and Qualification Engineer (m/f/d)Main Responsibilities:
- Leading assigned Commissioning, Qualification and Validation (CQV) activities including but not limited to equipment, processes, cycles, sterilization, transport, etc.
- Development and approval of CQV Plans and Reports.
- Support equipment and systems owners by providing technical knowledge
- 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 aregulations regarding safety and CQV activities
- Potential to be a sub-system owner for qualification and validation topic
- 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 for specific topics
- 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, Engineering or comparable work experience
- Work experience or theoretical knowledge in a Pharmaceutical Company preferably in Aseptic Processing operations.
- Hands-On-Experience or knowledge of CQV, (Bio) Process Technology, Microbiology, Aseptic Processing Equipment Design
- Experienced in or knowledge on the qualification and validation of cleanrooms, sterilization processes and aseptic process media simulation
- Experience or knowledge in risk management, change management, deviations and CAPAs management
- Energetic and enthusiastic team player with innovative mindset, strategic, analytical and problem-solving skills
- Fluency in written and spoken German and English. Very good knowledge of MS-Office applications
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