About the role
A career at Resilience is more than just a job – it’s an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. For more information, please visit www.resilience.com The CSV Engineer III independently plans, executes, and leads validation activities across facility, utility, process, cleaning, automation, and computer systems, with deep specialization in automation and computer system validation (CSV). Working within the process team concept,
the role applies independent technical judgment to resolve complex validation challenges, requires no instruction on routine work, and partners across engineering, quality, and operations to keep systems compliant and inspection-ready. As a technical advisor to the validation function, it coaches less-experienced team members and builds alignment on validation strategy and approach. Job
Responsibilities Validation Execution & Technical Leadership Independently plan, author, and execute validation deliverables — validation plans, protocols (IQ/OQ/PQ), and summary reports — for automation and computerized systems in accordance with GAMP 5 and applicable cGMP
requirements. Lead the qualification and lifecycle management of automated equipment and GxP computer systems (e.g., PLC, SCADA, DCS), including 21 CFR Part 11 and data integrity (ALCOA+) compliance. Serve as a technical advisor on validation strategy and risk-based approach across the facility, utility, process, and cleaning validation portfolio. Lead and coordinate validation studies and investigations with minimal supervision, applying independent technical judgment to resolve complex issues. Communicate project priorities, risks, and progress to the process team on a continuing basis. Identify and drive continuous-improvement opportunities in validation methodology, automation, and documentation practices. Documentation & Compliance Prepare and review validation documentation, ensuring activities, actions, and results are accurate, complete, and audit-ready. Answer compliance and process questions from cross-functional partners and serve as a subject-matter resource during regulatory and internal audits. Initiate and document appropriate corrective action when process deviations or system non-conformances occur, escalating issues beyond established procedures as needed. Maintain validated state through change control, periodic review, and requalification activities. Leadership, Coaching & Mentorship Provide technical coaching and guidance to less-experienced engineers and technicians on validation methodology and automation best practices. Build alignment across engineering, quality, and operations on validation