Technical Writer / Validation Specialist - (Life Sciences)
Shrive Technologies LLCWest Point, PA, United States18 hours ago
Job type
- Full-time
- Quick Apply
Job descriptionDevelop 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.
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Technical Specialist • West Point, PA, United States
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