CSV Lead

Job Title: CSV Lead Location: King of Prussia, PA (Onsite)

Experience: 8 - 10 Years Type: Contract

Job Description

We are seeking a CSV Lead with 12+ years of experience in validating GxP systems. The role requires deep expertise in CSV activities across applications such as SAP, MES, and Product Serialization systems. The ideal candidate has strong knowledge of compliance requirements, risk-based validation approaches, and experience working with both Agile and Waterfall methodologies.

Key Responsibilities

Lead and execute end-to-end validation of GxP applications.

Perform compliance reviews of GxP systems to ensure adherence to regulatory requirements.

Prepare and review Requirement Specifications, Functional Specifications, User Stories, and Acceptance Criteria.

Ensure test scripts have complete traceability to requirements and risk levels.

Review pre- and post-executed test protocols for completeness, accuracy, evidence, and defect management.

Author validation deliverables including Validation Plans, RTMs, and Validation Summary Reports.

Ensure operational procedures for validated applications are established and followed.

Handle small-scale change implementations including impact assessments, implementation plans, test results, defect tracking, and documentation.

Support compliance activities by acting as CSA, Validation SME, and Test Manager as required.

Serve as single point of contact for system assurance and compliance activities for assigned geography and functional scope.

Manage stakeholder relationships, address feedback, and ensure customer satisfaction.

Guide and mentor teams on validation and compliance best practices.

Work with tools such as ALM, DMS, and JIRA.

(Good to have) Experience implementing US-DSCSA compliance.

Qualifications

• 8+ years’ hands-on experience in Computer System Validation in regulated environments.

• Strong background in GxP, GAMP, and risk-based validation methodologies.

• Proven experience with Agile and Waterfall SDLC processes.

• Excellent documentation, review, and audit preparation skills.

• Strong communication and stakeholder management experience.