Computer Systems Validation Engineer (CSV/CSA)

barrywehmiller; Raleigh (NC); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

Barry-Wehmiller Design Group is seeking a Computer Senior Validation Engineer to plan, develop, and execute computer system validation for manufacturing and automation systems in the Raleigh-Durham area. You will author validation plans, test cases, protocols, and reports, while coordinating with engineering, quality, and operations teams.

The role requires a strong foundation in CSV/CSA regulatory guidelines, risk-based validation approaches, and related life sciences or engineering experience.

Qualifications

• Expertise in Computer System Validation / Assurance, with hands-on protocol development
• 3-8 years of experience in a similar validation role in regulated industries
• Bachelor's degree in Engineering, Computer Science, Life Sciences or related field

Responsibilities

• Plan, develop, and execute computer system validation activities for manufacturing and automation systems
• Create validation plans, test cases, protocols, and reports; review requirements and design documents
• Collaborate with engineering, quality, and operations to maintain compliant documentation and processes

Skills

CSV/CSA expertise

Validation protocols

Experience 3-8 years

Engineering background

Regulatory knowledge FDA/GxP

Education

Bachelor's degree in Engineering/Computer Science/Life Sciences

Job description

About Us

BW Design Group is a fully integrated architecture, engineering, construction, system integration, and consulting firm committed to helping our clients realize their most critical goals from Strategy to Commercialization. As the only firm born from a manufacturing technology company to become an independent and fully integrated firm, we combine deep domain expertise in the manufacturing environment with an approach that is built to serve the dynamic needs of our clients. Rooted in our distinct culture of Truly Human Leadership, we cultivate the leaders who will define tomorrow and partner with our clients in the food & beverage, life sciences, industrial, and advanced technology industries to build the future of manufacturing and technology.

Barry-Wehmiller is a diversified global supplier of engineering consulting and manufacturing technology for the packaging, corrugating, sheeting and paper-converting industries. By blending people-centric leadership with disciplined operational strategies and purpose-driven growth, Barry-Wehmiller has become a $3 billion organization with nearly 12,000 team members united by a common belief: to use the power of business to build a better world.

Job Description

Who You'll Work WithYou will join one of our 50 offices in the US, be part of a committed team of over 2000 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.

What You'll Do

This full-time, on-site Computer Senior Validation Engineer (CSV/CSA) role is based in the Raleigh-Durham-Chapel Hill Area. The individual in this role will plan, develop, and execute computer system validation activities for manufacturing and automation systems, including authoring validation plans, test cases, protocols, and reports. Responsibilities include reviewing system requirements and design documents, performing risk assessments, and ensuring compliance with applicable regulatory and industry standards. The engineer will support software and hardware validation efforts, and collaborate with cross-functional teams such as engineering, quality, and operations. The role also involves maintaining documentation, and continuously improving validation processes and methodologies.

Qualifications

• Candidates should possess expertise in Computer System Validation / Assurance, including developing and executing validation protocols and documentation.
• This is a mid level senior validation engineer role and requires 3-8 years of experience.
• Full time permanent W-2 position. Principals only no C2C or sponsorship is available.
• Candidates should possess skills in developing and executing Test Cases, with experience in identifying defects, executing tests, and analyzing results.
• Candidates should possess a foundation in Engineering or Life Sciences
• Relevant skills such as knowledge of CSV/CSA regulatory guidelines (e.g., FDA, GxP, GAMP5, Data Integrity), risk-based validation approaches, and quality systems are beneficial.
• Bachelor's degree in Engineering, Computer Science,, Life Sciences or a related technical field, or equivalent practical experience.
• Strong analytical, documentation, and communication skills, with the ability to work collaboratively in multidisciplinary teams.
• Experience in manufacturing, life sciences, or other regulated industries is an advantage.
• Experience with laboratory instruments and bio process equipment is a plus.Prior experience working as a consultant is also a plus.

Our culture and commitment to our people is what sets us apart. We foster an environment of mutual respect, integrity, and unconditional interest in the individual and collective success of our professionals. Our model and entrepreneurial mindset offer a rewarding, challenging, and highly flexible path.

As a Computer Systems Validation Engineer, you will build a meaningful and fulfilling career with the support of professional development resources and mentorships including our First Year Experience program, Individual Development Plans, and Career Path resources and tools. You will be surrounded by exceptional talent who will support your development as