Principal Computer System Assurance Engineer

About the role

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. The ideal candidate will lead innovative CSA strategies that incorporate critical thinking, intended use, patient safety, product quality, data integrity, and process risk to determine the appropriate level of assurance and testing rigor. This position is all about helping project teams and clients transition from traditional validation approaches to practical, efficient, risk-based assurance models, all while ensuring strong compliance and providing defensible objective evidence.

Responsibilities

• 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.

Requirements

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, Quality, or a related discipline.
• 10+ years of experience in controls, automation, computerized systems, quality, validation, documentation, commissioning, qualification, or lifecycle compliance within regulated environments.
• Extensive knowledge of CSA, CSV, GAMP 5, 21 CFR Part 11, EU Annex 11, ALCOA+ data integrity principles, risk assessments, system development life cycle (SDLC), change control, configuration management, as well as manufacturing or quality systems.
• Proven ability to establish CSA strategies, enhance requirements traceability, improve the quality of test protocols, minimize unnecessary documentation burdens, and facilitate risk-based assurance decision-making.
• A DNA comprised of collaboration and teamwork.

Qualifications

• Demonstrated experience in the implementation of CSA programs for clients within the pharmaceutical, biotechnology, or other GxP-regulated sectors.
• Proficient in cloud-based GxP systems, operational technology validation, AI-enabled validation, digital quality technologies, and active participation in the ISPE/GAMP/CSA community.
• Extensive experience in mentoring multidisciplinary teams and facilitating client-facing business development initiatives.

Benefits

• 401k + match with prompt enrollment; employees are 100% vested upon entry.
• Prompt enrollment into Medical, Dental, and Vision benefits.
• Generous paid time off including paid vacation, paid holidays, paid family leave, and sick time.
• Learning and growth opportunities with training and continuing education from day one.