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Computer System Validation Lead
2 weeks ago
Position Summary
The Computer System Validation Engineer III will lead the development and approval of validation documentation, risk assessments, and conduct impact assessments of proposed changes to computerized systems at Fujifilm Diosynth Biotechnologies. This role requires expertise in computerized systems validation, knowledge of regulatory requirements, and excellent communication skills.
Key Responsibilities
- Validate Computer Systems
- Generate, obtain approvals, and execute validation deliverables for computerized systems and relevant infrastructure.
- Ensure documents meet regulatory and procedural requirements, including 21 CFR Part-11, Annex-11 Data Integrity, and GAMP5.
- Plan and organize validation activities amongst cross-functional groups.
- Provide status updates for validation activities related to day-to-day operations or project work.
- Review all System Delivery Life Cycle (SDLC) deliverables.
- Provide constructive feedback to ensure deliverables adhere to associated Standard Operating Procedures (SOPs).
Requirements
- Master's Degree with 2+ years of direct experience in Validation in a pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments, OR;
- Bachelor's Degree with 4+ years of direct experience in Validation in a pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments, OR;
- Associates Degree with 6+ years of direct experience in Validation in a pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments.
