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
At Barry-Wehmiller we recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job. If your experience is close to what you see listed here, please still consider applying. We know that our differences often can bring about innovation, excellence and meaningful work—therefore, people from all backgrounds are encouraged to apply to our positions. Please let us know if you require reasonable accommodations during the interview process.
Barry-Wehmiller is an equal opportunity employer. M/F/D/V This organization uses E-Verify.
Applicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments.
Company
Design Group
