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United Consulting Hub · 3 weeks ago

CSV Analyst Entry Level

United States

Contract

Remote

Entry Level

1+ years exp

United Consulting Hub is seeking an entry-level CSV Analyst to support the validation of computerized systems in pharmaceutical and life sciences environments. The role involves ensuring systems are compliant with regulatory requirements, maintaining validation documentation, and supporting quality and compliance activities.

ConsultingInformation TechnologyProperty & Casualty InsuranceRisk Management

H1B Sponsor Likely

Hiring Manager

Deepak Pakalwad

Responsibilities

Assist in the validation of computerized systems (LIMS, ERP, MES, SCADA)

Prepare and execute validation documents (URS, IQ, OQ, PQ)

Ensure compliance with GMP, GAMP 5, and 21 CFR Part 11

Support validation planning, risk assessments, and change control activities

Maintain validation documentation in accordance with Good Documentation Practices (GDP)

Assist with audits, inspections, deviations, and CAPA activities

Collaborate with QA, IT, Engineering, and business teams

Support data integrity and system compliance initiatives

Qualification

Computerized System Validation (CSV) lifecycleUser Requirements Specification (URS)Installation Qualification (IQ)Operational Qualification (OQ)Performance Qualification (PQ)Manufacturing Practice (GMP)GAMP 521 CFR Part 11Laboratory Information Management System (LIMS)Enterprise Resource Planning (ERP)Manufacturing Execution System (MES)Supervisory Control and Data Acquisition (SCADA)Data IntegrityDocumentation Practices (GDP)

Required

Bachelor's degree in Life Sciences, Engineering, Computer Science, IT, or a related field

1–2 years of experience (internship/project experience considered)

Basic knowledge of CSV lifecycle (URS, IQ, OQ, PQ), GMP, and GAMP 5

Familiarity with computerized systems and data integrity principles

Strong documentation, analytical, communication, and problem-solving skills

Preferred

Exposure to LIMS, SAP, MES, SCADA, or other GxP systems

Knowledge of ALCOA+, ISO 9001, and regulated environments

Internship or academic project in Computerized System Validation, QA, or IT systems

Company

United Consulting Hub

United Consulting Hub is a business consulting company that provides risk management and information technology services.

Founded in 2021

Metuchen, New Jersey, USA

51-200 employees

https://unitedconsultinghub.com

H1B Sponsorship

United Consulting Hub has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

88%

Represents job field similar to this job

Engineering and Development

Customer Service and Support

Trends of Total Sponsorships

*2026 (6)

2025 (28)

2024 (15)

2023 (1)

Funding

Current Stage

Growth Stage

Leadership Team

Babjee M.

Founder

Company data provided by crunchbase