Computer System Validation (CSV) Consultant / CSV Validation Lead (AI & SAP Systems)

Hi

I hope you are doing well.

We have an urgent position listed below. Please send your most recent resume along with the expected rate if you are interested.

Role: Computer System Validation (CSV) Consultant / CSV Validation Lead (AI & SAP Systems)

Location -Raritan, NJ(Hybrid)

Job Details:

• 5+ years of Computer System Validation (CSV) experience in GxP-regulated environments, with hands-on validation and deployment of SAP ERP, WMS, and enterprise supply chain applications; strong knowledge of CSA, GAMP 5, 21 CFR Part 11, Annex 11, and audit/inspection readiness.

• Demonstrated delivery experience with Generative AI and Agentic AI solutions, including validation/governance of AI-enabled systems, LLM-based applications, AI agents, orchestration frameworks, prompt/model lifecycle controls, and risk-based compliance approaches in regulated environments.

• Experience 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.

• 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

• 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, System/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

–

Shailendra Rajak

Raas infotek corporation

262 Chapman road, Suite 105A, Newark, DE-19702

Phone no. 302-565-0220, Ext. 145

Email id: [email protected]

LinkedIn:linkedin.com/in/shailendra-r-9904ba27b