
Nityo Infotech Corporation
Hybrid in Raritan, New Jersey • Today
Easy Apply
Contract
Depends on Experience
11 results (2 new)

Nityo Infotech Corporation
Hybrid in Raritan, New Jersey • Today
Easy Apply
Contract
Depends on Experience









Role CSV Validation Lead
Location -Raritan, NJ(Hybrid)
Job Details:
5+ years of Computer System Validation (CSV) experience in GxP-regulated environments, with hands-on experience in retro-validation activities and 21 CFR remediation projects with knowledge of CSA, GAMP 5, 21 CFR Part 11, Annex 11, and audit/inspection readiness.
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
🤯 Applying directly to the forehead...
Hybrid in Raritan, New Jersey
•
2d ago
Role - Validation Lead Location - Raritan, NJ (Hybrid) W2/C2C Job Details: 5+ years of Computer System Validation (CSV) experience in GxP-regulated environments, with hands-on experience in retro-validation activities and 21 CFR remediation projects with knowledge of CSA, GAMP 5, 21 CFR Part 11, Annex 11, and audit/inspection readiness. Experience in the Pharmaceutical, biotechnology, or medical device industry Experience in FDA and/or Global regulated environment with good understanding of GxP
Easy Apply
Contract, Third Party
55 - 60
Hybrid in Raritan, New Jersey
•
Today
Job Role - Validation Lead Location -Raritan, NJ (Hybrid) Job Details: 5+ years of Computer System Validation (CSV) experience in GxP-regulated environments, with hands-on experience in retro-validation activities and 21 CFR remediation projects with knowledge of CSA, GAMP 5, 21 CFR Part 11, Annex 11, and audit/inspection readiness. Experience in the Pharmaceutical, biotechnology, or medical device industry Experience in FDA and/or Global regulated environment with good understanding of GxP stan
Easy Apply
Full-time
55 - 60
Hybrid in Raritan, New Jersey
•
9d ago
We are seeking an experienced CSV Consultant with expertise in Computer System Validation (CSV), SAP ERP, and Generative AI/Agentic AI in a GxP-regulated environment. The ideal candidate will have strong experience validating enterprise applications while ensuring compliance with FDA and global regulatory standards. Key Responsibilities: Perform Computer System Validation (CSV) activities for SAP ERP, WMS, and enterprise applications.Develop and execute validation documentation, including Valida
Easy Apply
Contract
45 - 50
Raritan, New Jersey
•
Today
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Contract
USD45.0/HOURLY - USD52.0/HOURLY