Sr. Staff 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. And were 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 weve 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. Weve already changed millions of lives and were 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. Well get there by constantly reinventing unique biosensing-technology experiences. Though weve 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.

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 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

Preferred Qualifications:

• 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

What youll 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:

• 5-15%

Experience and Education Requirements:

• Typically requires a Bachelors degree in a technical discipline and a minimum of 13 years related experience or a Masters degree and 8 years equivalent industry experience or a PhD and 5 years of experience

Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may at its discretion assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin or protected veteran status and will not be discriminated against on the basis of disability. Dexcoms AAP may be viewed upon request by contacting Talent Acquisition at

If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process please contact Dexcom Talent Acquisition at

Meritain an Aetna Company creates and publishes the Machine-Readable Files on behalf of Dexcom. To link to the Machine-Readable Files please click on the URL provided: 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.

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