Computer System Validation (CSV) C&Q Technical Lead-Automation
JC Automation Corp · Posted Nov 13, 2026
- Carolina, Puerto Rico, Puerto Rico
- Lead
The Computer System Validation (CSV) C&Q Technical Lead for Automation plays a critical role in ensuring that automated systems within the manufacturing environment meet all regulatory and quality standards.
Responsibilities
- Partner with process engineering to ensure automation requirements are aligned with business needs.
- Manage technical changes and provide technical direction through all software development and testing activities.
- Partner with the Design Verification Lead to ensure alignment between CSV and verification expectations.
- Provide direction for CSV strategy, validation approach, and major CSV deliverables (Requirements, Design, Security Plan, Test Plan, etc.).
- Lead development and execution of Commissioning and Qualification (C&Q) protocols (IQ/OQ/PQ) for automation and control systems.
Requirements
- Bachelor's degree in Automation, Controls, Chemical/Electrical Engineering, Computer Science or a related field or an equivalent combination of education and relevant experience.
- Nice to have: prior experience as an Automation Lead or CSV/C&Q Technical Lead on a large-scale pharmaceutical or biotech capital project