CSV Consultant Job at ClinDCast LLC, Somerville, NJ

  • ClinDCast LLC
  • Somerville, NJ

Job Description

Job Description

Job Description

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 Validation Plans, Requirements, Test Protocols, Traceability Matrix, and Validation Summary Reports.
  • Validate AI-enabled systems, including Generative AI, Agentic AI, LLM-based applications, AI agents, and orchestration frameworks.
  • Ensure compliance with GAMP 5, CSA, 21 CFR Part 11, Annex 11, and GxP regulations.
  • Review and approve system testing, UAT scripts, design specifications, and validation deliverables.
  • Support audit and inspection readiness activities.
  • Collaborate with cross-functional and remote teams to deliver validation projects.
  • Provide validation guidance and support multiple projects simultaneously.
Required Skills:

  • 5+ years of Computer System Validation (CSV) experience in GxP-regulated environments.
  • Strong experience with SAP ERP (mandatory).
  • Experience validating Generative AI , Agentic AI , LLM-based applications, and AI governance.
  • Knowledge of GAMP 5, CSA, FDA regulations, 21 CFR Part 11, Annex 11, and risk-based validation.
  • Experience in the pharmaceutical, biotechnology, or medical device industry.
  • Excellent documentation, analytical, communication, and problem-solving skills.

Flexible work from home options available.

Job Tags

Remote work, Flexible hours

Similar Jobs

Champion Homes

Production Worker - General Worker Job at Champion Homes

 ...Production Worker Opportunity Good Life Begins With A Good Company. Champion Home Builders, Inc. wants YOU! We are seeking to...  ...for every employee. FLSA Status: Non-exempt Summary Under general supervision, work on the production line to build manufactured... 

Hampton Golf Inc

Lifeguard Job at Hampton Golf Inc

 ...of water test conditions for the inspection of the local health agency. Vacuum pool bottom, empty automatic skimmers, and skim bugs...  ...Ability to consistently lift, carry and load adaptive and other sports equipment that may weigh 50 or more pounds, and sustain aerobic... 

MANTECH

SharePoint Developer Job at MANTECH

 ...relevant experience, or a high school diploma/GED plus 8 years of SharePoint experience. We need experience building complex, custom...  ...senior-level briefings and reports. Responsibilities: We develop SharePoint-enabled solutions that meet design goals. We... 

Talented Medical Solutions

Registered Nurse (RN) / Labor & Delivery Job at Talented Medical Solutions

 ...Nursery preferred. BEDS - 14 Patient Ratio: varied (Labor 1:1-2, Nursery 1:6, Postpartum 1:6, MB 1:3 couplets) SCRUB...  ...FROM FACILITY Position Title Travel: Registered Nurse (RN) / Labor & Delivery Nights Position Type Travel Specialty RN - L&D... 

Cummins

Design Engineer Job at Cummins

 ...Job Title Mechanical Design Engineer Job Description In this role, you will make...  ...of materials, ensuring compliance with industry, customer, and organizational standards....  ...or sanctions regulations. Experience: Entry level/Early career professional. Preferred...