Senior CSV & GxP Validation Lead | Life Sciences

TechDigital Group; King of Prussia (PA); On-site; USD 120,000 - 180,000; Full time

Job summary

TechDigital Group is seeking an experienced CSV and QA professional in the United States (King of Prussia area) to lead validation activities for GxP systems. You will perform end-to-end system validation, risk assessments, and change management within FDA GxP contexts and regulatory standards.

The role requires expertise with ALM/DMS/JIRA tools, familiarity with SAP, serialization, and MES environments, and the ability to work in Agile and Waterfall projects.

Qualifications

• 10+ years of experience validating systems in GxP environments.
• Experience in CSV activities for SAP, Product Serialization and MES systems.
• End-to-end validation knowledge and ability to assess regulatory compliance.

Responsibilities

• Review system assurance deliverables to ensure regulatory compliance.
• Perform validation activities using Agile and Waterfall methodologies.
• Develop and maintain Validation Plans and Validation Summary Reports with traceability matrices.
• Lead change control, risk assessments and RTM updates for GxP systems.
• Coordinate QA activities and collaborate with regional stakeholders.

Skills

Computer System Validation

GAMP

GxP risk assessments

Change Management

JIRA

Veeva / Argus

Tools

ALM

DMS

JIRA

Job description

TechDigital Group is seeking an experienced CSV and QA professional in the United States (King of Prussia area) to lead validation activities for GxP systems. You will perform end-to-end system validation, risk assessments, and change management within FDA GxP contexts and regulatory standards.

The role requires expertise with ALM/DMS/JIRA tools, familiarity with SAP, serialization, and MES environments, and the ability to work in Agile and Waterfall projects.