Computer Systems Validation Engineer (CSV/CSA)

BW Design Group; Raleigh (NC); Presencial; USD 90.000 - 130.000; Jornada completa

Descripción de la vacante

BW Design Group in the Raleigh-Durham area is seeking a Computer Systems Validation Engineer to plan and execute validation activities for manufacturing and automation systems. You will author validation plans, test cases, protocols, and reports while ensuring compliance with regulatory standards.

The role involves collaborating with engineering, quality, and operations teams, performing risk assessments, and maintaining robust validation documentation.

Formación

• Experience in Computer System Validation/Assurance
• Knowledge of CSV/CSA regulatory guidelines (FDA, GxP) is beneficial
• Strong analytical, documentation, and communication skills
• Experience in manufacturing or life sciences is an advantage
• Consulting experience is a plus

Responsabilidades

• 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.
• Support software and hardware validation efforts and collaborate with cross-functional teams.
• Maintain documentation and continuously improve validation processes and methodologies.

Conocimientos

CSV/CSA knowledge

Validation protocols

Risk-based validation

Documentation

Communication

Educación

Bachelor's degree in Engineering/CS/Life Sciences

Descripción del empleo

Who You’ll Work With

You 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.

Who You’ll Work With

You 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 both a world-class engineer and a highly effective leader.

Feel like you're on the path to becoming a Computer Systems Validation Engineer but you're not quite there yet? We'd love to connect with you to see if we can take you from where you are today and grow you into a Design Group Engineering Consultant.