Principal Computer System Assurance Engineer

At E Tech Group , j oining our team means joining a group of passionate and forward-thinking experts.

We’re one of the largest engineering and system integration firms in the United States providing value for our clients thr ough IT automation and control solutions for more than 30 years to the Life Sciences, Mission Critical, Metals & Mining , Warehousing & Distribution , and CP G/ Food & Beverage industries.

Our national and global scale allows us to help our clients develop and implement standardized solutions at any of their facilities regardless of physical location or the local resources available at that site.

We are seeking a Principal Computer System Assurance Engineer to join our team!

In this role, you will provide senior quality, validation, documentation, commissioning, qualification, and lifecycle compliance leadership for our regulated life sciences projects.

You will be a principal technical authority and a client-facing Computer System Assurance (CSA) leader, supporting a variety of systems including laboratory, manufacturing, utility, automation, cloud, and IT/OT.

You will:

• Be the go-to CSA, quality, documentation, and validation resource for our exciting projects, programs, and client accounts.
• Help E Tech Group develop and lead innovative CSA strategies for GxP computerized systems, automation platforms, manufacturing systems, laboratory systems, cloud-based applications, and IT/OT solutions.
• Utilize risk-based assurance methods, including scripted testing, unscripted testing, supplier documentation leverage, vendor assessment, automated evidence, and targeted verification to ensure top-notch quality.
• Review and enhance our validation plans, assurance plans, requirements, risk assessments, traceability matrices, test protocols, commissioning and qualification documentation, executed records, and summary reports.
• Support audits, investigations, deviations, CAPAs, change controls, lifecycle assessments, proposals, RFQs, CSA workshops, and engaging client quality discussions.
• Mentor our talented engineers, project leaders, and quality resources in CSA principles, data integrity, Good Documentation Practice, and risk-based testing practices.
• Serve as an ambassador who embodies our Core Values , prioritizing the success of E Tech Group, our clients, and the professional development of our associates.

You have:

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, Quality, or a related discipline.