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Senior Validation Engineer
Il y a 2 mois
We are seeking a highly motivated and experienced Senior Validation Engineer - Analytical Equipment to join our team at Evotec WD. As a key member of our Quality Assurance department, you will play a critical role in ensuring the quality and compliance of our analytical equipment.
Key Responsibilities- Develop and implement validation strategies for analytical equipment, ensuring compliance with industry regulations and company policies.
- Collaborate with cross-functional teams, including Quality Control, Manufacturing, and Process Engineers, to ensure seamless integration of validation activities.
- Lead the generation and review of key deliverables, including User Requirements Specifications, System Impact Assessments, and Commissioning, IQ, OQ, and PQ protocols.
- Contribute to the development of qualification and validation programs, ensuring alignment with regulatory requirements and company policies.
- Support the execution of commissioning, IQ, OQ, and PQ activities, ensuring timely completion and quality of deliverables.
- Perform periodic review and requalification of qualified equipment, systems, and utilities to ensure continued suitability and compliance.
- Develop and implement corrective actions to address validation deviations and ensure compliance with regulatory requirements.
- Master's degree in engineering science or a related field, with 8+ years of relevant experience in a GMP environment.
- Strong understanding of industry standards and best practices for analytical equipment validation.
- Working knowledge of US FDA CFRs, European EMA, and ICH regulations.
- Experience authoring and reviewing validation documentation, including User Requirements Specifications and Commissioning, IQ, OQ, and PQ protocols.
- Strong problem-solving and critical thinking skills, with the ability to adapt to a fast-paced and dynamic environment.
- Excellent communication and collaboration skills, with the ability to work effectively with cross-functional teams.
- Fluency in English and French, with the ability to communicate effectively in both languages.
Evotec WD is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. Our team is dedicated to creating access and value for a global market through scientific and technological innovation. We are committed to diversity and inclusion, and we welcome applications from candidates with disabilities.
