Senior Computer System Validation Lead

Position Overview

The Senior Computer System Validation Lead will lead end-to-end CSV lifecycle activities for manufacturing systems, including MES and automation systems. They will act as the CSV Lead/SME for manufacturing programs, providing guidance on validation strategy, execution, and compliance. The role also involves supporting validation for systems like MES, SAP EWM, Tulip, SCADA, PLC, and other GMP-regulated applications.

Requirements

• 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.

Benefits

• Competitive compensation package
• Full Benefits; Medical, Vision, Dental, and more!
• Opportunity to get in with an industry leading organization