Senior Validation Engineer - Remote, FDA 21 CFR Part 11

RXinsider LTD.; Conshohocken (Montgomery County); Hybrid; USD 90,000 - 140,000; Full time

Job summary

Cencora is seeking a qualified professional to support computer system validation, ensuring alignment with regulatory standards and company policies. You will lead requirements gathering, design system integration, and prepare comprehensive validation documents across VP, IQ/OQ/PQ, RTM, and VSR, while collaborating with project managers and operations teams.

Proven experience with FDA 21 CFR part 11, GxP, and database validation is required.

Qualifications

• Bachelor’s degree in CS, Engineering or related field
• Five years of experience in electronic document management and validation
• Experience with FDA 21 CFR part 11 and GxP compliance

Responsibilities

• Support computer system validation by aligning operations with requirements and policies.
• Lead gathering of business requirements and system integration design.
• Prepare Validation Protocols, RTM, VMPs, and Validation Reports.
• Interact with cross-functional teams and ensure regulatory compliance.

Skills

SQL queries

Validation testing

GxP compliance

FDA 21 CFR part 11

Documentation management

Education

Bachelor's degree in Computer Science/Engineering

Master's degree in Computer Science/Engineering

Tools

KeatGX

HP Quality Center

Team Foundation Server (TFS)

Microsoft SQL databases

Job description

Cencora is seeking a qualified professional to support computer system validation, ensuring alignment with regulatory standards and company policies. You will lead requirements gathering, design system integration, and prepare comprehensive validation documents across VP, IQ/OQ/PQ, RTM, and VSR, while collaborating with project managers and operations teams.

Proven experience with FDA 21 CFR part 11, GxP, and database validation is required.