Validation Specialist

TechDigital Group; West Point (PA); On-site; USD 70,000 - 90,000; Full time

Job summary

A life sciences consulting firm is seeking a Validation Specialist to develop and maintain standard operating procedures and validation documentation. The role involves translating complex scientific concepts into clear documents and ensuring compliance with industry standards. Candidates should have experience with regulatory requirements and electronic document management systems. This position is based in West Point, Pennsylvania.

Qualifications

• Experience in developing and maintaining SOPs and other validation documents.
• Strong understanding of regulatory standards including GxP, ISO, ICH.
• Familiarity with electronic document management systems.

Responsibilities

• Develop and maintain SOPs, user manuals, and validation protocols.
• Translate scientific concepts into clear documentation.
• Collaborate with SMEs to verify technical information.
• Ensure compliance with industry standards.
• Manage document lifecycle in EDMS.
• Author and execute validation protocols for software and processes.
• Perform Computer System Validation as per regulations.
• Conduct risk assessments and support change controls.
• Review validation documentation.

Job description

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.