Lead Validation Engineer – Remote (FDA/GxP)

Cencora; Conshohocken (Montgomery County); Remote; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

Paid parental leave

Job summary

Cencora is seeking a senior validation professional to lead computer system validation in the pharmaceutical space. You will ensure alignment with system requirements, corporate policies, industry standards, and regulatory guidelines, while guiding cross-functional teams through validation activities.

The role involves preparing and executing Validation Protocols, supporting documentation, and working with SQL databases and EDC systems. Remote work options are available.

Qualifications

• Bachelor's degree in Computer Science, Engineering or related field; 5+ years in validation roles.
• Experience in pharmaceutical healthcare with FDA 21 CFR part 11 and GxP; knowledge of validation protocols.
• Expertise in writing and executing Validation Protocols, RTMs, VSRs and Change Controls.
• Experience with Electronic Document Management Systems and configuration management tools.

Responsibilities

• Support computer system validation aligning with requirements, policies, standards, and regulations.
• Lead gathering of business requirements and system integration design; perform risk assessments and validation testing.
• Prepare, execute, and analyze validation protocols (VP, BRD, IQ/OQ/PQ), RTM, release memo, and VSR; manage change control.

Skills

Validation testing

Risk assessment

SQL queries

Test documentation

Cross-functional collaboration

Education

Bachelor's degree in Computer Science/Engineering or related

Master's degree in the same fields (optional with 3 years experience)

Tools

KeatGX

SQL databases

Job description

Cencora is seeking a senior validation professional to lead computer system validation in the pharmaceutical space. You will ensure alignment with system requirements, corporate policies, industry standards, and regulatory guidelines, while guiding cross-functional teams through validation activities.

The role involves preparing and executing Validation Protocols, supporting documentation, and working with SQL databases and EDC systems. Remote work options are available.