Senior Computer System Validation Lead

**Job Title: Senior Computer System Validation Lead** **Location:** Concord, NC (Complete Onsite) **Position Overview:** We are seeking a Senior Computer System Validation Lead to join our team for an onsite opportunity in Concord, NC. This role involves leading validation strategies and executing validation activities for manufacturing systems within a regulated environment, primarily in the life sciences or pharmaceutical industry. The ideal candidate will collaborate with cross-functional teams to ensure compliance with regulatory standards and support digital manufacturing initiatives. **Key Responsibilities:** - Lead end-to-end CSV lifecycle activities for manufacturing systems, including MES and automation systems. - Act as CSV Lead/SME for manufacturing programs, providing guidance on validation strategy, execution, and compliance. - Support validation for systems such as MES, SAP EWM, Tulip, SCADA, PLC, and other GMP-regulated applications. - Author, review, and approve validation documentation, including Validation Plans, URS, FS/DS, IQ/OQ/PQ Protocols, and system summaries. - Ensure compliance with FDA, GAMP5, GxP, Data Integrity principles, and internal quality systems. ** :** - 10+ years of experience in Computer System Validation within regulated manufacturing environments (Pharma/Biotech/Medical Devices). - Strong hands-on experience with MES validation and automation-integrated systems. - Proven experience working in shop-floor environments and automation systems. - Expertise in GAMP5 risk-based validation, FDA 21 CFR Part 11 & Annex 11 compliance, and Data Integrity (ALCOA+). - Ability to lead cross-functional teams, handle regulatory inspections, and manage stakeholders across IT, Quality, and Manufacturing.