Sr. Staff IT Validation Engineer

DexCom • Mesa, AZ

9h

About The Position

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: 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. Where you come in: 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 MiniTab). Assumes and performs other duties as assigned.

Requirements

• 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 Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO 13485 Quality management systems)
• 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.
• Prior managerial skills preferred.
• Excellent written and verbal communication skills, with hands-on experience creating CSV documentation
• Excellent organizational skills and attention to detail
• Typically requires a Bachelor’s degree in a technical discipline, and a minimum of 13+ years related experience or a Master’s degree and 8+ years equivalent industry experience or a PhD and 5+ years of experience

Nice To Haves

• Proven experience with all levels of SDLC artifacts for 21 CFR Part 11 impacted systems
• Proven expertise in delivering full cycle CSV programs to deliver 21 CFR Part 11 compliance across both IT systems and OT (Operations Technology) systems (such as MES, PLC)
• Proven expertise creating and executing Computer System Validation Plans & Protocols
• Proven managerial skills in leading teams, and cross-functional collaboration
• Medical device or regulated industry experience strongly preferred.
• ASQ SQE (Software Quality Engineer) certification
• Expertise in 21 CFR Part 11
• Familiarity with 21 CFR 820 a plus
• Experienced in validating manufacturing automation solutions including MES, SCADA, PLC, Data Historians, EBR

Responsibilities

• 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 MiniTab).
• Assumes and performs other duties as assigned.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees