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Technical Writer / Validation Specialist - (Life Sciences)

Technical Writer / Validation Specialist - (Life Sciences)

Shrive Technologies LLCWest Point, PA, United States
1 day ago
Job type
  • Full-time
  • Quick Apply
Job description
  • 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.
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    Technical Specialist • West Point, PA, United States

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