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 joins the Regulatory Compliance Practice and works with industry experts, technical specialists, and clients to deliver validation solutions. The position is described as full-time and on-site in the Raleigh-Durham-Chapel Hill Area. The engineer plans, develops, and executes computer system validation activities for manufacturing and automation systems. The work includes authoring validation plans, test cases, protocols, and reports; reviewing requirements and design documents; conducting risk assessments; supporting software and hardware validation; and ensuring compliance with applicable regulatory and industry standards. The role also includes collaborating with engineering, quality, and operations teams, maintaining documentation, and continually improving validation processes and methodologies. The company describes a collaborative, flexible culture with professional development resources and mentorship, including its First Year Experience program, Individual Development Plans, and Career Path resources and tools. This is a permanent W-2 position. No C2C or sponsorship is available.
Requirements
- 3–8 years of experience; the role is described as mid-level/senior.
- Expertise in Computer System Validation / Assurance, including developing and executing validation protocols and documentation.
- Skills in developing and executing test cases, identifying defects, executing tests, and analyzing results.
- A foundation in Engineering or Life Sciences.
- A 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.
- Permanent W-2 employment; no C2C or sponsorship is available.
Nice To Haves
- Knowledge of CSV/CSA regulatory guidelines, such as FDA, GxP, GAMP5, and Data Integrity.
- Knowledge of risk-based validation approaches and quality systems.
- Experience in manufacturing, life sciences, or another regulated industry.
- Experience with laboratory instruments and bioprocess equipment.
- Prior experience working as a consultant.
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 teams, including engineering, quality, and operations.
- 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
