Regulatory Compliance Engineer
6 days ago
Job Description
Fujifilm Diosynth Biotechnologies is seeking a highly skilled Computer System Validation Engineer III to join our team. This role requires expertise in computerized systems validation, knowledge of regulatory requirements, and excellent communication skills.
Responsibilities and Qualifications
- 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.
- Lead Validation Activities
- 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 SDLC Deliverables
- Review all System Delivery Life Cycle (SDLC) deliverables.
- Provide constructive feedback to ensure deliverables adhere to associated Standard Operating Procedures (SOPs).
- 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.
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