Join to apply for the Computer Systems Validation Engineer role at BW Design Group When you join Design Group as a Computer Systems Validation Engineer, you become part of a team that challenges you and supports your growth. In this role, you will collaborate with industry experts to help leading companies solve complex problems. You will join our Regulatory Compliance Practice, working alongside seasoned leaders, technical specialists, and subject matter experts to deliver high-quality, consistent solutions to our clients. What You’ll Do Interface with clients and take responsibility for preparing and executing computer system validation documents for various control and production systems. Develop and execute validation test scripts, including SFATs, HFATs, traceability matrices, IQs, and OQs. Participate in good documentation practices (cGMP and FDA CQV). Read engineering documents, prioritize tasks, and manage multiple projects simultaneously. Communicate effectively both verbally and in writing. Make a daily impact with your skills, strengthening relationships with clients and team members. What You’ll Bring At least four years of validation experience in regulated industries such as pharmaceutical, biotech, or medical devices. Knowledge of FDA Data Integrity requirements, risk assessments, and gap analyses. Understanding of GAMP and 21 CFR Part 11. Experience with software lifecycle documentation like FRSs, SDSs, HDSs, and configuration specs. Hands-on experience with platforms like Emerson DeltaV, Syncade, Allen Bradley PLC, Wonderware, OSI PI, or Rockwell. Knowledge of laboratory systems and CSV for process control in clean utilities and bioprocessing. Understanding of biologic operations, including fermentation and purification. Willingness to travel for project needs, including installation, startup, and industry events. Bachelor’s degree in engineering, computer science, or related field. Our culture emphasizes mutual respect, integrity, and individual growth. We support your professional development through mentorship, development plans, and career resources. Join us to build a rewarding career surrounded by talented professionals who will support your growth as both an engineer and leader. #J-18808-Ljbffr BW Design Group
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