Computer Systems Validation Lead - Hybrid

Smart IMS•Bridgewater, NJ

4d•Hybrid

About The Position

The Computer Systems Validation Lead is a key member of CSV projects and drives validation deliverables. The role provides guidance and support to ensure client computerized systems are deployed following lifecycle management and remain in a validated state in accordance with applicable SOPs, regulatory requirements, and security requirements. The lead provides strategic direction on CSV strategy, manages multiple projects, authors and reviews validation documents, oversees testing, and maintains CSV documentation in Veeva. The role also trains, coaches, and mentors GxP system owners.

Requirements

Bachelor’s degree in computer science, engineering, life sciences, or a related field.
5–10+ years of hands-on experience in a validation role, with responsibility for computer systems, specifically Veeva systems such as Veeva Quality, Veeva QMS, and Veeva RIMS.
Experience validating GAMP Category 5 (custom-built/bespoke) systems.
Experience with AI tools/applications and assessing the GxP relevance of AI use cases.
Solid working knowledge of CSV guidelines and FDA/EU regulations, including 21 CFR Part 11, Annex 11, GAMP 5, GMPs, Good Clinical Practices, and data integrity.
Strong technical writing skills for authoring, reviewing, and approving validation plans, requirements, testing documents, and summary reports.
Knowledge and understanding of fundamental FDA Computer Software Assurance (CSA) concepts.
Strong customer service skills for internal and external customers.
Ability to multitask across different projects and prioritize work effectively.

Responsibilities

Provide strategic leadership and decision-making on CSV strategy using the client’s risk-based approach.
Develop CSV strategies for different systems and applications, including AI tools and applications.
Oversee and manage multiple projects simultaneously and drive CSV deliverables.
Author CSV documents, including Validation Plans and Summary Reports.
Assist with or co-author requirements, UFRS/FRS, IQ, OQ, and PQ protocol scripts, specifications, and other validation project deliverables.
Ensure project team members complete training requirements, including CSV SOP, test execution, and Gdoc training.
Guide project team members to ensure they follow established CSV plans.
Provide real-time oversight and support during test execution and review executed protocols.
Route CSV documents for approval.
Manage and maintain CSV documents in Veeva.
Train, coach, and mentor GxP system owners.