CSV Consultant

Role - CSV Consultant
Location -, NJ(Hybrid)

Rate - $ 50/hr on W2 and $ 60/hr C2C

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

Best Regards,
Rahul Thakur
Phone: 760-349-0078
Email: rahul@dantatechnologies.net

Notes:- All qualified applicants will receive consideration for employment without regard to race, color, religion, religious creed, sex, national origin, ancestry, age, physical or mental disability, medical condition, genetic information, military and veteran status, marital status, pregnancy, gender, gender expression, gender identity, sexual orientation, or any other characteristic protected by local law, regulation, or ordinance.

Benefits: Danta offers a compensation package to all W2 employees that are competitive in the industry. It consists of competitive pay, the option to elect healthcare insurance (Dental, Medical, Vision), Major holidays and Paid sick leave as per state law.

The rate/ Salary range is dependent on numerous factors including Qualification, Experience and Location.