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KPG99 INC · 23 hours ago

Validation Specialist

North Carolina, United States

Contract

Hybrid

Senior Level

5+ years exp

KPG99 INC is seeking a Validation Specialist for a contract position. The primary responsibility of this role is to ensure compliance with regulatory standards in Computer System Validation (CSV) within GxP environments.

ConsultingSalesStaffing Agency

H1B Sponsor Likely

Hiring Manager

Rama Kumari

Qualification

Computer System Validation21 CFR Part 11GAMP 5EU Annex 11ICH Q9ALCOA+ principlesValidation documentationStakeholder managementLab instrument softwareDocumentation skillsCommunication skills

Required

5+ years of hands-on Computer System Validation (CSV) experience in GxP environments

Strong knowledge of: 21 CFR Part 11

Strong knowledge of: EU Annex 11

Strong knowledge of: GAMP 5

Strong knowledge of: ICH Q9

Strong knowledge of: ALCOA+ data integrity principles

Proven experience creating and executing validation documentation (URS, IQ/OQ/PQ)

Experience working with lab instrument software

Excellent documentation, communication, and stakeholder-management skills

Company

KPG99 INC

Our business consulting services are led by significant domain depth built on a robust technology-driven services platform.

Founded in 2013

Hampton, New Jersey, USA

51-200 employees

https://www.kpg99.com/

H1B Sponsorship

KPG99 INC 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

Represents job field similar to this job

Trends of Total Sponsorships

2025 (3)

2024 (5)

2023 (1)

2022 (1)

2021 (1)

2020 (5)

Funding

Current Stage

Growth Stage

Company data provided by crunchbase