IT Validation & Verification Engineer
Dexcom Inc
The Company
Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health.
We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us.
Meet the team:
Our Global Shop Floor Systems group is an enterprise team that develops and applies our digital strategy to Dexcom’s manufacturing operations. We work with leading edge hardware and software technologies to seamlessly integrate our shop floor systems within the organization to enable optimal operational and business performance.
In this role, you will provide strategic guidance and validation leadership across projects and initiatives within the Sustaining Quality and Information Technology Operations teams, with a primary focus on supporting the validation and testing of complex automated IT systems and architectures. You will be responsible for overseeing and executing Computer System Validation processes in alignment with regulatory and internal standards, ensuring systems meet compliance, reliability, and performance requirements. The position requires extensive cross-functional collaboration, interfacing with departments including Information Technology, Quality Assurance, Operations, Engineering, R&D, Regulatory Affairs, Marketing, Legal, Customer Operations, senior management, and external vendors. Your expertise will be instrumental in driving validation excellence and ensuring that IT projects are delivered with robust, compliant, and well-documented validation frameworks.
Where you come in:
- You will act as subject matter expert to develop and support verification and validation activities for Equipment and Process (IQ/OQ/PQ/PPQ), Test Method Validations, Computer Software Assurance methodology and Validation Master Planning.
- You will provide QA & QC requirements for IT & OT systems
- You will provide guidance / expertise on GxP risk-assessment at system level, functionality level, and data element level
- You will provide guidance / expertise on EU MDR as well as 21 CFR 820 & 21 CFR Part 11
- You will actively participate as a core advisor to the IT/OT teams.
- You will effectively communicate with broad Dexcom teams and upper-level management on project progress and challenges.
- You will apply risk management, validation, sample size, and external standards review and implementation activities.
- You will apply techniques such as six sigma and Total Quality Management to improve Dexcom operations.
- You will design and apply company policies and procedures that help Dexcom achieve its quality policy and compliance with domestic and international regulations. Some examples could include equipment, process, software and test method validation, auditing, calibrations, CAPA, customer complaint processing, document control, nonconforming materials, process controls, receiving inspection, training.
- You will improve systems and processes that improve product safety; increase product consistency and conformance to requirements; improve production efficiency; reduce operating and scrap costs.
- You are able to interpret, draft, and apply specifications and inspection criteria effectively, utilizing the appropriate inspection tools configured to meet required standards.
- You have proficient computer skills in the use of Microsoft Office and database applications (e.g. Excel and MiniTab).
- Other duties as assigned
What makes you successful:
- Experience with validation of enterprise computer systems as used in pharmaceutical and/or medical device environments, such as Electronic Document Management Systems, Manufacturing Execution Systems, Enterprise Resource Planning Systems, Clinical Data Management Systems, and/or Laboratory Information Management Systems.
- Must have a thorough understanding of GxP-related business processes and Quality Systems, and FDA electronic records/signature requirements and computer validation expectations
- Knowledge and understanding of global regulations such as FDA 21 CFR part 820, FDA 21 CFR part 11, ISO 13485 etc.
- Experience with providing risk-based quality guidance for IT & OT systems, ideally with experience in med device / discrete manufacturing
- Knowledge and understanding of FDA Computer System Assurance (CSA) principles and methodology.
- Must be able to work independently to perform a project management role within cross-functional teams and with projects of varying degrees of complexity
- Excellent written and verbal communication skills, with hands-on experience creating CSV documentation
- Excellent organizational skills and attention to detail
- Personnel in this role must be systematic, highly organized and articulate and work in a team environment. A positive attitude is important while working in a fast-paced environment and dealing with shifting priorities
What you’ll get:
- A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community.
- A full and comprehensive benefits program.
- Growth opportunities on a global scale.
- Access to career development through in-house learning programs and/or qualified tuition reimbursement.
- An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.
Travel Required:
- 20% initially, reducing to 10% in 2026
To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.