Sr. IT Validation Engineer

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. We are broadening our vision beyond diabetes to empower people to take control of health with 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. The opportunity to improve health on a global scale stands before us.

The IT/OT Validation Engineer provides guidance for the projects, functions, and strategic objectives of the Sustaining Quality and Information Technology Operations groups, concentrating on: the validation and testing support for complex automated information technology applications and architecture. The position may be responsible for Computer System Validation processes and execution and will require interfacing with all functions (Information Technology, Quality Assurance, Operations, Engineering, R&D, Regulatory Affairs, Marketing, Legal, Customer Operations, upper levels of management, and vendors).

The focus of this role will be focused on providing Validation leadership and management to IT projects and teams. 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.

• Act as subject matter expert to develop and support verification and validation activities for Enterprise Systems (e.g. Camstar/MES systems, ERP systems, QMS systems) and Process (IQ/OQ/PQ/PPQ), Test Method Validations, Computer Software Assurance methodology and Validation Master Planning.
• Provide QA & QC requirements for IT & OT systems
• Provide guidance / expertise on GxP risk-assessment at system level, functionality level, and data element level
• Provide guidance / expertise on EU MDR as well as 21 CFR 820 & 21 CFR Part 11
• Actively participate as a core advisor to the IT/OT teams.
• Effectively communicates with broad Dexcom team and upper level management on project progress and challenges.
• Applies risk management, validation, sample size, and external standards review and implementation activities.
• Applies techniques like six sigma and Total Quality Management to improve Dexcom operations.
• Designs and applies 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.
• Improves systems and processes that improve product safety; increase product consistency and conformance to requirements; improve production efficiency; reduce operating and scrap costs.
• Reads, writes, and understands specifications and inspection criteria to apply criteria using appropriate and properly configured inspection tools.
• Applies proficient computer skills in the use of Microsoft Office and database applications (e.g. Excel and Mini Tab).
• Assumes and performs other duties as assigned.

• 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 the FDA 21 CFR 820 and ISO 13485 Quality management systems
• Experience with providing risk-based quality guidance for IT & OT systems, ideally with experience in medical 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. Prior managerial skills preferred.
• Excellent written and verbal…