CSV Consultant

CYNET SYSTEMS

  • Raritan, NJ
  • 1 day ago
  • $48–$53 Per Hour
  • Temporary
  • Contractor
  • Part-time
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Skills

  • Acceptance Testingunmatched
  • Accidental Death and Dismemberment (AD&D)unmatched
  • Artificial Intelligence (AI)unmatched
  • Artificial Intelligence (AI) Agentsunmatched
  • Biologyunmatched
  • Biotech and Pharmaceuticalunmatched
  • Communication Skillsunmatched
  • Compensation and Benefitsunmatched
  • Computer Systemsunmatched
  • Consultingunmatched
  • Dental Insuranceunmatched
  • Disability Insuranceunmatched
  • Documentationunmatched
  • Employee Assistance Planunmatched
  • FDA (Food and Drug Administration)unmatched
  • Fortune 500 Customersunmatched
  • Governmentunmatched
  • GxPunmatched
  • ISO (International Organization for Standardization)unmatched
  • ISO 14001unmatched
  • ISO 9001unmatched
  • Information Technology & Information Systemsunmatched
  • Insuranceunmatched
  • Medical Equipmentunmatched
  • Multitaskingunmatched
  • Presentation/Verbal Skillsunmatched
  • Quality Assurance Methodologyunmatched
  • Regulatory Complianceunmatched
  • Requirements Managementunmatched
  • Riskunmatched
  • Risk Managementunmatched
  • SAP ECC (fka SAP R/3 and SAP ERP)unmatched
  • State Laws and Regulationsunmatched
  • Supply Chain Management Softwareunmatched
  • System Testunmatched
  • System Validationunmatched
  • Team Lead/Managerunmatched
  • Team Playerunmatched
  • Technical Recruitingunmatched
  • Test Scriptsunmatched
  • Testingunmatched
  • Time Managementunmatched
  • Traceabilityunmatched
  • Validation Planunmatched
  • Validation Testingunmatched
  • Vision Planunmatched
  • Writing Skillsunmatched

Description

Job Overview:

Pay Range: $48hr - $53hr

Requirement/Must Have:

  • 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.

Benefits
 
Our Benefits Include:
  • Medical, Dental, and Vision Insurance
  • 401(k) Retirement Plan
  • Health Savings Account (HSA)
  • Disability Insurance (Short-Term and Long-Term)
  • Life and AD&D Insurance
  • Paid Sick Leave (where required by applicable state or local law)
  • Supplemental Insurance Plans
  • Identity Theft Protection
  • Pet Insurance
  • Employee Wellness Programs
  • Employee Assistance Program (EAP)
  • Career Growth and Professional Development Opportunities
Disclaimer: Benefits eligibility, accrual rates, and usage limits may vary based on employment status, length of service, and work location. Paid Sick Leave is provided in strict accordance with applicable state and municipal mandates. Cynet Systems Inc. reserves the right to modify, amend, or terminate any benefit plans at any time in accordance with applicable laws.

About Cynet Systems

Founded in 2010 and headquartered in the Washington, DC metro area, Cynet Systems Inc. is a leading technology staffing and workforce solutions company serving Fortune 500 companies, government agencies, and enterprise organizations across the United States and Canada. We deliver agile, scalable talent solutions across IT, engineering, life sciences, clinical, and professional staffing, powered by a high-performing recruitment engine operating across North America and Asia.
As a nationally and locally certified Minority Business Enterprise (MBE), Cynet Systems is committed to helping organizations build high-performing teams while empowering professionals to grow rewarding careers. Our organization is certified to ISO 9001, ISO 14001, ISO 27001, and SOC 2 Type II standards, reflecting our commitment to quality, security, operational excellence, and customer success.

Numbers & Facts

LocationRaritan, NJ
Job TypeTemporary, Contractor, Part-time
Salary$48–$53 Per Hour
HeadquartersRaritan, NJ, US

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