Validation Engineer III
5 days ago
FUJIFILM Diosynth Biotechnologies Texas, LLC is seeking a highly skilled Validation Engineer III to join our team. As a key member of our validation team, you will be responsible for planning and organizing validation activities across cross-functional groups, generating and executing validation deliverables, and ensuring compliance with regulatory and procedural requirements.
Key Responsibilities:- Develop and execute validation protocols, deviations, and validation summary reports
- Utilize Validation Life Cycle Concept and apply single-use technology
- Employ GMP, GDP, GLP practices and guidelines, including 21CFR Part11 & Part210, 50, 56, 58, EU Annex 11, ICH (IND, NDA), USP, ASME, and ISPE
- Review FUSE System Delivery Life Cycle (SDLC) deliverables and ensure adherence to Standard Operating Procedures (SOPs)
- Update SOPs, forms, templates, documentation, and files
- Bachelor's Degree in Information Systems Security, Biotechnology, Pharmaceutical Science, or related field
- Five (5) years of experience in a validation role, including five (5) years of validation experience in a pharmaceutical, biotechnology, or related industry
- OR Master's Degree in Information Systems Security, Biotechnology, Pharmaceutical Science, or related field and two (2) years of experience in a validation role
$109,000 - $115,000
How to Apply:Please apply directly at [insert link]
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