Computer System Validation

Role - CSV IT Validation Engineer (LSMV / Pharmacovigilance System)

Location - Raritan, NJ(Hybrid)

Key Responsibilities

• Candidates need to have hands-on experience in validating GxP GEN AI based solutions and LSMV Safety and Pharmacovigilance system

• Ability to manage multiple dispositions for multiple J&J Managers with limited supervision.

• Ability to manage end-end from Inventory, assessments, remediations to final dispositions; 7-10 years of relevant experience; has experience of leading/advising Junior and Senior resources. Specifically in the Pharmaceutical, biotechnology, or medical device industry.

• Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation; Define and implement Risk based validation activities.

• Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Reports, SOPs/WIs). Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs Experience in QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures.

• Strong verbal and written communication skills.

• Ability to work as a team player, lead a team or accomplish tasks without supervision.

• Ability to work with remote teams and support several changes/projects simultaneously.

• Ability to provide Validation guidance, timely reviews, and escalations to TQ management

Hiring: Kneat C&Q Implementation Consultant

📍 Princeton, NJ | Hybrid – Minimum 3 Days/Week Onsite

Contract | GxP / Pharma

Skills Required:

• Kneat C&Q Platform
• C&Q Implementation
• GxP Applications
• CSV / CSA
• SaaS Applications
• Enterprise Application Support
• Validation & UAT
• Application Deployment
• Incident / Break-Fix Support
• Vendor Management

Preferred: Veeva, ValGenesis, or similar C&Q/Quality platforms

Key Responsibilities:

• Support Kneat implementation, testing, validation, deployment & go-live
• Coordinate with vendors, IT, Business and Quality/Validation teams
• Troubleshoot application issues and manage incidents
• Transition the application from implementation to steady-state support
• Maintain technical documentation and compliance activities
• Support releases, upgrades, patches and enhancements