CSV Lead

Role - CSV Lead

Location- Durham, NC (Hybrid, must visit site 2-3 days a week)

Job Description-

Must have worked in CSV in Manufacturing automation systems like DELTA V,PI Historian, PLC, LAB Automation Systems(any one pf the systems or all).

Primary: CSV (Computer System Validation) Compliance

Secondary: SDLC / CSA / Validation Governance / Quality Compliance.

Hands-on experience supporting validation and compliance activities for computerized manufacturing systems in a regulated pharmaceutical environment.

Familiar with Kneat,SNOW,Veeva Systems.

Provide CSV compliance support for Capital and Strategic Projects to ensure continuity of compliance oversight and project delivery.

Develop, review, and approve validation lifecycle deliverables in accordance with GxP requirements, internal SOPs, and regulatory expectations.

Provide compliance guidance to project teams on SDLC, CSA (Computer Software Assurance), qualification, risk-based validation, and change control processes.

Strong experience in Computer System Validation (CSV) within GMP-regulated pharmaceutical/manufacturing environments.

Knowledge of Validation Lifecycle, CSA, SDLC, Qualification (IQ/OQ/PQ), Change Control, CAPA, and Risk Management.

Experience reviewing and approving validation documentation and compliance deliverables.

Familiarity with GxP regulations, Data Integrity, FDA, EMA, and industry compliance requirements.