Validation Test Lead

TechDigital Group; King of Prussia (PA); On-site; USD 100,000 - 130,000; Full time

Job summary

A leading technology firm in King of Prussia is seeking a seasoned professional to ensure regulatory compliance through extensive validation of GxP applications. The successful candidate will have at least 12 years of experience and will manage testing teams throughout the validation lifecycle, employing Agile and Waterfall methodologies. This role offers competitive compensation and responsibilities in a dynamic environment.

Qualifications

• 12 years of experience in validating systems and GxP applications.
• Adept with Agile and Waterfall methodologies.

Responsibilities

• Perform reviews to ensure regulatory compliance per customer SOPs.
• Execute end-to-end validation of GxP applications.
• Manage testing teams across the entire validation testing life cycle.

Skills

Validation Testing

Hands-on experience in ALM/Codebeamer

Jira

Life Science Domain

Job description

Overview

Job details describe a role requiring extensive experience in validating systems and GxP-related applications, with responsibility for reviewing GxP systems to ensure regulatory compliance per customer SOPs. The position involves end-to-end validation of GxP applications, with document/process compliance analysis and familiarity with Agile and Waterfall methodologies.

Responsibilities

• 12 years of experience in validating systems and GxP-related applications. Perform reviews to ensure regulatory compliance per customer SOPs. Execute end-to-end validation of GxP applications and conduct document/process compliance analysis. Adept with Agile and Waterfall methodologies.
• Define requirement specifications, functional specifications/User stories/acceptance criteria, and ensure completeness of test scripts with traceability. Ensure risk assessment is completed for all requirements and that test cases are designed in reference to identified risk levels.
• Onsite Test Lead with management of testing teams across the entire validation testing life cycle, including test planning, test case design, test execution, and defect management activities.
• Author Validation Plan and compile Validation Summary Report, generate RTM, conduct reviews, and ensure Operational Procedures for the application are prepared. Manage small change implementations related to change requirements.

Must Have

• Validation Testing
• Hands-on experience in ALM/Codebeamer, Jira, Life Science Domain