Computer System Validation Engineer

Computer Systems Validation Engineer 

Who You'll Work With 

You will join one of our 45 offices in the US, be part of a committed team of over 1600 professionals, and work in teams and directly with our clients doing work that is shaping the world around us. You will be welcomed into a rapidly growing business and team and empowered to make an impact. You will be valued, cared for, and challenged on your path to becoming a world-class professional consultant and surrounded by leaders who are committed to creating an environment that enables you to realize your own success and fulfillment. 

When you join Design Group as a Computer Systems Validation Engineer, you are joining a team that will challenge you and position you for growth. In this role, you will work with a team of industry experts to help the world’s leading companies solve their most difficult problems. You will join our Regulatory Compliance Practice and partner with seasoned leaders, technical specialists, and subject matter experts to deliver the highest quality solutions to our clients with consistency and accuracy. #LI-TH1

What You'll Do 

In this role, you'll be responsible for supporting capital projects and delivering computer systems validation solutions for FDA-regulated clients. You'll work closely with clients, project teams, technical specialists, and Regulatory Compliance Practice leaders to prepare, execute, and document validation activities for production, process control, and stand-alone systems. This position plays an important role in helping clients maintain compliant, reliable systems, giving you the opportunity to apply technical expertise across complex life sciences projects. 

• Prepare and execute computer systems 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 

• Apply cGMP, FDA CQV methods, and good documentation practices throughout validation deliverables 

• Review engineering documents, set priorities, and manage validation activities across multiple projects 

• Support capital projects by implementing practical validation solutions aligned with client requirements 

• Collaborate with clients and project teams to communicate technical findings, deliverable status, and project needs 

• Use technical writing skills to create clear validation documentation and support compliant project execution 

• Apply computer systems validation expertise to strengthen client relationships and support high-quality delivery 

What You'll Bring 

Qualifications 

• Bachelor's degree in engineering, computer science, or a related technical field 

• 5+ years of computer systems validation experience in pharmaceutical, biotech, medical device, or other FDA-regulated industries 

• Working knowledge of GAMP5 and 21 CFR Part 11 requirements 

• Experience generating software development life cycle documentation, including FRSs, SDSs, HDSs, or configuration specifications 

• Ability to travel for project requirements, including installation and start-up activities, client and company meetings, trainings, seminars, forums, and conventions 

• Solid understanding of ALCOA+ principles 

Preferred Qualifications 

• Competency with FDA Data Integrity requirements and exposure to data integrity risk or gap assessments 

• Hands-on experience with platforms such as Emerson DeltaV, Syncade, Allen Bradley PLC, Wonderware, OSI PI, or Rockwell software 

• Experience with laboratory systems, process control systems, clean utilities, bioprocess manufacturing equipment, or biologic unit operations