Lead CSV & Validation Engineer – GxP/Separation Expert

Creative Solutions Services, LLC

Raritan (NJ)

On-site

USD 90,000 - 130,000

Full time

14 days+

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Job summary

Creative Solutions Services, LLC seeks a seasoned Validation lead with strong GxP and CSV expertise. The role focuses on independent support for business separation activities of large global GxP systems, including acquisition/divestiture projects.

You will guide junior and senior staff, collaborate with remote teams, and manage end-to-end validation across infrastructure and cloud-based applications. Experience in regulated environments, risk-based validation, and comprehensive validation

Qualifications

Experience in FDA- or Global-regulated environments with GxP standards and risk-based validation.
Ability to define and implement risk-based validation activities.
Experience in writing and executing documentation for validation deliverables (requirements, validation plans, test protocols, test reports, SOPs).
Experience in QA methodologies, designing and approving test plans, test scripts and procedures.

Responsibilities

Lead/advise junior and senior resources in CSV and validation projects.
Support Business Separation activities for large global and regional GxP computerized systems with minimal supervision.
Manage end-to-end validation processes from inventory, assessments, remediations to final dispositions.
Work with remote teams and support multiple changes/projects simultaneously.