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.
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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
