Technical WriterValidation Specialist

West Point, UT - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Develop and maintain SOPs user manuals validation protocols and regulatory submission documents.
Translate complex scientific and technical concepts into clear concise documentation.
Collaborate with SMEs to gather and verify technical information.
Ensure documentation complies with industry standards (GxP ISO ICH).
Manage document lifecycle using electronic document management systems (EDMS).
Author and execute validation protocols (IQ/OQ/PQ) for equipment software and processes.
Perform Computer System Validation (CSV) in accordance with 21 CFR Part 11 and GAMP 5.
Conduct risk assessments and support change control processes.
Review and approve validation documentation and reports.

Develop and maintain SOPs user manuals validation protocols and regulatory submission documents. Translate complex scientific and technical concepts into clear concise documentation. Collaborate with SMEs to gather and verify technical information. Ensure documentation complies with industry standa...