Validation Engineer III
2 weeks ago
FUJIFILM Diosynth Biotechnologies Texas, LLC is seeking a highly skilled Validation Engineer III to join our team.
Job Summary:We are looking for a talented individual to work in the biotechnology industry, providing and maintaining status updates for validation activities related to day-to-day operations or project work. The successful candidate will plan and organize validation activities amongst cross-functional groups, generate, obtain approvals, and execute validation deliverables for FUSE systems and relevant infrastructure.
Key Responsibilities:- Work in biotechnology industry providing and maintaining status updates for validation activities related to day-to-day operations or project work.
- Plan and organize validation activities amongst cross-functional groups.
- Generate, obtain approvals, and execute validation deliverables for FUSE systems and relevant infrastructure.
- Review all FUSE System Delivery Life Cycle (SDLC) deliverables and ensure that the deliverables adhere to associated Standard Operating Procedures (SOPs).
- Update SOPs, forms, templates, documentation, and files.
- Execute validation protocols, deviations, and validation summary reports.
- Utilize Validation Life Cycle Concept.
- Apply single use technology.
- Utilize FUSE systems including Clean Room Facilities, Clean Room Utilities, Smoke studies, Sterilization with Steam / VHP.
- Lab Equipment (ie. HPLC, UPLCs, UVVis and pH meters).
- Utilize temperatures mapping tools including E-Val Pro/ValSuite/Kaye System.
- Employ GMP, GDP, GLP practices including 21CFR Part11 & Part210, 50, 56, 58, EU Annex 11, ICH (IND, NDA), USP, ASME and ISPE guidelines.
- Bachelor's Degree in Information Systems Security, Biotechnology, Pharmaceutical Science, or related field.
- Five (5) years of experience in position offered or related position 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 position offered or related position including two (2) years of validation experience in a pharmaceutical, biotechnology, or related industry.
$109,000 - $115,000
How to Apply:Please apply directly at [insert link]
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