CSV Engineer III

National Resilience
west chester, OH$80k–$118kPosted Jun 26, 2026
Skip to main contentThis website stores cookies on your computer. These cookies are used to collect information about how you interact with our website and allow us to remember you. We use this information in order to improve and customize your browsing experience and for analytics and metrics about our visitors both on this website and other media. To find out more about the cookies we use, see our Privacy Policy.If you decline, your information won’t be tracked when you visit this website. A single cookie will be used in your browser to remember your preference not to be tracked.Read Full Privacy MessageDeclineAccept CookiesCareersSign InCSV Engineer III page is loadedCSV Engineer IIIApplylocationsUSA - OH - West Chestertime typeFull timeposted onPosted 21 Days Agojob requisition idR-106937A 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.comThe 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 ResponsibilitiesValidation Execution & Technical LeadershipIndependently 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 & CompliancePrepare 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 & MentorshipProvide 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 requirements and acceptance criteria.May oversee and direct the validation activities of others within assigned projects.Experience & EducationMinimum QualificationsDemonstrated experience in validation or process engineering.Demonstrated ability to independently lead validation studies and projects...

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