Validation Specialist (Life Sciences) Develop and maintain SOPs, user manuals, validation protocols, and regulatory submission documents. Manage document lifecycle using electronic document management systems (EDMS).
Numbers & Facts
Location
West Point, PA
Industry
Other/Not Classified
Company Size
100 to 499 employees
Description
Validation Specialist (Life Sciences)
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.