Computer Systems Validation Engineer (CSV/CSA)
About The Position
BW Design Group is a fully integrated architecture, engineering, construction, system integration, and consulting firm serving clients in food and beverage, life sciences, industrial, and advanced technology industries. The Computer Systems Validation Engineer will join the Regulatory Compliance Practice and work with industry experts and clients to address complex challenges. This full-time, on-site role is based in the Raleigh-Durham-Chapel Hill area and is described as a mid-level/senior validation engineering position. The engineer will plan, develop, and execute computer system validation activities for manufacturing and automation systems, while collaborating with engineering, quality, and operations teams. The position is a permanent W-2 role; C2C arrangements and sponsorship are not available. The role involves preparing and maintaining validation documentation, reviewing requirements and design documents, conducting risk assessments, and ensuring compliance with applicable regulatory and industry standards. The engineer will contribute to software and hardware validation efforts and continuously improve validation processes and methodologies. Design Group describes a people-focused culture and offers professional development resources and mentorship, including a First Year Experience program, Individual Development Plans, and career path resources.
Requirements
- 3–8 years of experience in computer systems validation or related validation engineering work.
- Expertise in Computer System Validation/Assurance, including developing and executing validation protocols and documentation.
- Experience developing and executing test cases, identifying defects, executing tests, and analyzing results.
- Foundation in engineering or life sciences.
- Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related technical field, or equivalent practical experience.
- Strong analytical, documentation, and communication skills.
- Ability to work collaboratively in multidisciplinary teams.
Nice To Haves
- Knowledge of CSV/CSA regulatory guidelines, including FDA, GxP, GAMP5, and data integrity.
- Experience with risk-based validation approaches and quality systems.
- Experience in manufacturing, life sciences, or other regulated industries.
- Experience with laboratory instruments and bioprocess equipment.
- Prior consulting experience.
Responsibilities
- Plan, develop, and execute computer system validation activities for manufacturing and automation systems.
- Author validation plans, test cases, protocols, and reports.
- Review system requirements and design documents.
- Perform risk assessments and ensure compliance with applicable regulatory and industry standards.
- Support software and hardware validation efforts.
- Collaborate with cross-functional engineering, quality, and operations teams.
- Maintain validation documentation.
- Continuously improve validation processes and methodologies.
- Develop and execute test cases, identify defects, and analyze test results.
Benefits
- Professional development resources and mentorship.
- First Year Experience program.
- Individual Development Plans.
- Career path resources and tools.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
