DTI Validation Lead at Qcs Staffing in North Carolina, United States | Kablio

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DTI Validation Lead

Employer undisclosedRole managed by a recruiter

Lead validation strategy for digital tech systems in a new biotech plant

12 days ago ago

Experienced (8-12 years), Expert & Leadership (13+ years)

Contractor

North Carolina, United States

Onsite

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Founded with the aim of providing top-tier staffing solutions for diverse sectors.
Focus on long-term partnerships with clients, ensuring the right talent for specialized roles.
Expert in recruiting for both large-scale projects and niche, high-demand sectors.
Has become a trusted partner in sectors such as Industrial, Energy, and Infrastructure.
Notable for a rapid response to market demands and changing industry trends.
Experience in delivering recruitment services for large infrastructure and energy projects.
Specializes in sourcing skilled professionals for both permanent and temporary roles.
Recognized for working on complex and large-scale projects with a diverse client base.

About the client

About the client

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Role

Description

validation docs

data integration

validation strategy

csv planning

Ensure validation deliverables (URS, FS/DS, IQ/OQ/PQ, risk assessments, etc.) are created, reviewed, and approved per project timelines.
Collaborate with engineering, automation, IT, quality, and construction teams to ensure integration and data flow meet compliance and data integrity standards.
Develop and own the validation strategy for digital technology systems (e.g., MES, DCS/SCADA, Historian, lab systems, asset management tools, and digital workflow platforms).
Lead CSV (Computer System Validation) planning and execution.

Requirements

csv

automation

it validation

leadership

capex

gamp 5

Extensive experience in CSV/automation/IT validation within pharmaceutical or biotech manufacturing.
Proven leadership in cross-functional environments and vendor/contractor management.
Experience supporting greenfield/brownfield CAPEX projects highly preferred.
Strong knowledge of GAMP 5, Data Integrity principles (ALCOA ), and GMP regulations.

Benefits

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Training + Development

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Interview process

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Visa Sponsorship

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Security clearance

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