Wunderlich-Malec Engineering (WM) is a 100% employee-owned ESOP and one of the largest and most well-established engineering companies in the United States. When you join WM, you become part of a company that is: 100% employee-owned with 40+ years of industry history ENR (Engineering News Record) Top 500 firm Rated as a top System Integrator Giant We have a Computer System Validation Engineer position. This role will ensure that all computer systems and software used in manufacturing and laboratory environments comply with regulatory requirements and industry standards. The responsibilities include developing, executing, and maintaining validation protocols and documentation to support the validation lifecycle of GxP systems. Job Responsibilities: Interface with clients and prepare and execute computer system validation documents for distributed control, process control, and stand-alone production systems Develop and execute validation test scripts, including SFATs, HFATs, traceability matrices, IQs, and OQs Ensure validation activities comply with regulations such as GxP, FDA, or ISO standards Work directly with clients to understand their needs and meet project requirements Assist with the design, development, and implementation of Manufacturing Execution System (MES) solutions Job Requirements: Education: Bachelor of Science in Engineering, Computer Science, or related field Experience: 4+ years preferred in areas such as: Computer system validation in pharmaceutical, biotech, medical device, or FDA-regulated industries Data integrity requirements and risk assessments GAMP and 21 CFR Part 11 standards Software development lifecycle documentation MES deployment (e.g., PAS-X, Syncade, POMS) Hands-on experience with platforms like Emerson DeltaV, Allen Bradley PLC, Wonderware, OSI PI, Ignition, Rockwell Knowledge of laboratory systems and CSV for process control systems Willingness to design and implement MES in life sciences environments Strong communication skills Self-motivated and proactive Willingness to travel up to 25% Physical Demands: Seeing, color perception, hearing, clear speech, manual dexterity, driving, lifting, mounting/dismounting equipment, pushing, and pulling. Working Conditions: Standard office, on-site, and industrial environments, frequent computer use, fax, copy machines, and phones. #LI-Hybrid #LI-DW1 Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities. Applicants will be notified of their rights under federal employment laws. For more information, review the Know Your Rights notice from the Department of Labor. #J-18808-Ljbffr