Remote Senior Validation Engineer – Pharma Systems

MWI Animal Health; Conshohocken (Montgomery County); Hybrid; USD 95,000 - 140,000; Full time

Benefits offered by this job

Fully remote work availability

Medical, dental, and vision benefits

Professional development & mentorship

Job summary

Cencora is seeking a Senior Validation Engineer to support computer system validation across operations, ensuring compliance with FDA 21 CFR Part 11 and GxP. You will lead requirement gathering, risk assessments, and validation testing, coordinating with cross-functional teams.

The role offers fully remote work with strong emphasis on documentation and QA deliverables. Qualifications include a BS in CS/Engineering and 5+ years in pharma/healthcare validation, with EDMS experience and SQL

Qualifications

• Bachelor’s degree (or foreign equivalent) in Computer Science/Engineering or related, plus 5 years' experience in validation in pharma/healthcare.
• Experience with EDMS, validation protocols (VP, BRD, IQ/OQ/PQ, RTM, Release Memo, VSR).
• Experience with FDA 21 CFR Part 11 and GxP (GCP, GDP).
• Writing queries in Microsoft relational databases to verify data; KeatGX for tracking/testing.

Responsibilities

• Support computer system validation aligning with requirements, policies, and regulations.
• Lead gathering of business requirements and system integration design; identify gaps and assess risks.
• Execute validation testing, resolve defects, produce validation deliverables (IQ/OQ/PQ, RTM, VSR).
• Prepare and maintain VMPs, RTMs, change controls; provide validation strategy decisions.

Skills

EDMS

Validation Protocols

FDA 21 CFR Part 11

SQL Queries

TFS/HP Quality Center

Education

Bachelor's degree in Computer Science or Engineering

Master's degree (optional) in related field

Tools

KeatGX

SQL Databases

RTM / VMP

QMS/Documentation Tools

Job description

Cencora is seeking a Senior Validation Engineer to support computer system validation across operations, ensuring compliance with FDA 21 CFR Part 11 and GxP. You will lead requirement gathering, risk assessments, and validation testing, coordinating with cross-functional teams.

The role offers fully remote work with strong emphasis on documentation and QA deliverables. Qualifications include a BS in CS/Engineering and 5+ years in pharma/healthcare validation, with EDMS experience and SQL