DTI Validation Lead

QCS Staffing; North Carolina; On-site; USD 100,000 - 130,000; Full time

Job summary

A leading staffing agency is seeking a DTI Validation Lead for a 12-month contract in North Carolina. The ideal candidate will develop and own the validation strategy for digital technology systems, lead CSV planning, and collaborate with engineering and quality teams to ensure compliance. Extensive experience in CSV within pharmaceutical or biotech manufacturing is required. This role offers a unique opportunity to contribute to the establishment of a new biomanufacturing plant on the East Coast.

Qualifications

• Extensive experience in CSV/automation/IT validation within pharmaceutical or biotech manufacturing.
• Experience supporting greenfield/brownfield CAPEX projects highly preferred.
• Strong knowledge of GAMP 5, Data Integrity principles (ALCOA), and GMP regulations.

Responsibilities

• Develop and own the validation strategy for digital technology systems.
• Lead CSV planning and execution.
• Collaborate with cross-functional teams to ensure compliance and data integrity.

Skills

CSV/automation/IT validation

Leadership in cross-functional environments

Vendor/contractor management

Tools

MES

DCS/SCADA

Asset management tools

Job description

DTI Validation Lead - US, North Carolina - 12 Months Initial Contract

Our client, a globally recognized pioneer in Biotechnology, is recruiting for the position of DTI Validation Lead. A leader in the industry, our client focuses on areas of high unmet medical need and leverages its expertise to stride for solutions. This is your chance to join them on their global mission to better the lives of those affected by disease and illness. The project at hand is for the construction of a new build biomanufacturing plant based located on the East Coast.

What You'll Do

• 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.
• Collaborate with engineering, automation, IT, quality, and construction teams to ensure integration and data flow meet compliance and data integrity standards.
• Ensure validation deliverables (URS, FS/DS, IQ/OQ/PQ, risk assessments, etc.) are created, reviewed, and approved per project timelines.

What You'll Need

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

If this role is of interest, please apply now.