Senior CSV Validation Engineer
3 weeks ago
Job Summary
We are seeking a highly skilled Senior CSV Validation Engineer to join our team at FUJIFILM Diosynth Biotechnologies. As a key member of our validation team, you will be responsible for ensuring the compliance of our computerized systems with regulatory requirements.
Key Responsibilities
- Provide oversight of validation activities, including the development and approval of validation documentation, risk assessments, and impact assessments of proposed changes to computerized systems.
- Lead the generation, obtaining approvals, and execution of validation deliverables for computerized systems and relevant infrastructure.
- Plan and organize validation activities amongst cross-functional groups, providing status updates for validation activities related to day-to-day operations or project work.
- Support regulatory and client audits as a CSV subject matter expert.
Requirements
- Master of Science Degree in Computer Science, Life Sciences, Engineering, or similar discipline with 3+ years of experience in computer system validation activities in pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments.
- Working knowledge of engineering principles, computerized systems validation, and 21 CFR Part 11, Annex 11, Data Integrity, GAMP5 requirements, and FDA industry regulations.
- Excellent written and oral communication skills, with the ability to work with minimal supervision.
About FUJIFILM Diosynth Biotechnologies
We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community, and the world at large. We are an equal opportunity and affirmative action employer, committed to providing a diverse and inclusive work environment.
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