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Validation Engineer
2 months ago
We are seeking a highly skilled Validation Engineer to join our team at On Q Recruitment. As a Validation Engineer, you will play a crucial role in ensuring the quality and compliance of our client's products in the cell and gene therapy sector.
Key Responsibilities- Validation Activities: Plan, coordinate, and monitor validation activities associated with changes to existing plant, equipment, and processes.
- Quality Management: Manage validation activities following the Quality Management System, Site Validation Master Plan, Business Improvement, and Validation procedures to meet regulatory requirements.
- Documentation: Prepare, implement, and maintain departmental documentation for validation activities and regulatory submissions.
- Collaboration: Build and maintain collaborative relationships with internal and external partners.
- Audits: Participate in internal and external audits to ensure compliance with regulatory requirements.
- Problem Solving: Participate in problem-solving and identify opportunities for improvement to optimize validation activities.
- Training: Ensure all training certification requirements are up-to-date.
- CQV Leadership: Provide cGMP leadership and guidance for the integration and delivery of CQV activities within the site.
- Education: Bachelor's degree in Science or Engineering with a major in Chemical Engineering.
- Experience: 5+ years' experience performing commissioning and/or qualification activities in an FDA-regulated industry.
- Skills: Strong knowledge of FDA regulations for viral vector manufacturing, Lean Six Sigma certification, and excellent time management and organizational skills.
