Validation Specialist

Overview

Validation Specialist (Life Sciences)

Responsibilities

• 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.

J-18808-Ljbffr