Quality Validation Engineer
Vor 2 Tagen
CAPGEMINI ENGINEERING is seeking a skilled CQV Engineer to join our team.
Key Responsibilities- Validation and Qualification: Develop and execute validation protocols to ensure processes, instruments, and facilities comply with regulatory standards.
- Commissioning and Qualification of Utilities: Commission and qualify utilities such as purified water systems, clean steam systems, HVAC systems, and compressed air systems.
- Equipment Commissioning and Qualification: Commission and qualify biotechnology equipment, including reactors, fermentation systems, downstream processing equipment, and cell culture systems.
- Cleaning Validation and Qualification: Validate and qualify cleaning processes and equipment, including procedure development, protocol preparation, sampling plan design, validation execution, verification, and monitoring.
- Documentation and Collaboration: Contribute to documentation of CQV activities and collaborate with cross-functional teams to optimize processes.
- Continuous Improvement: Implement continuous improvement initiatives.
- Regulatory Knowledge: Applied knowledge of international pharmaceutical regulations and standards.
- Language Skills: Demonstrated effective verbal and written communication skills in French and English (minimum B1/B2).
- Experience: Experience in one or more of the mentioned CQV specialties.
- Teamwork and Adaptability: Ability to work independently and collaboratively in a fast-paced, team-oriented environment.
- Travel: Willingness to travel within Switzerland.
- Remote Work: Between 30% and 70% remote work in agreement with your manager and client needs (40% for cross-border due to tax regulation).
- Equipment and Training: Options to order ergonomically proven equipment (monitor & chair) for your home-office premises and support for trainings, formation upon agreement with the manager.
- Wellness and Culture: Contribution on gym subscription and trust-based managerial culture.
We look forward to receiving your application. CAPGEMINI ENGINEERING only accepts direct applications (no recruitment agencies).
Due to Swiss regulations, we only consider Swiss or EU/EFTA applicants or applicants with a valid work permit.
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