Sr. Staff IT Validation Engineer

Dexcom • Mesa, AZ

2d

About The Position

Provides QA & QC requirements for IT & OT systems Improves systems and processes that improve product safety; increase product consistency and conformance to requirements; improve production efficiency; reduce operating and scrap costs. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time.

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.
• Experience with providing risk-based quality guidance for IT & OT systems, ideally with experience in med device / discrete manufacturing
• 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
• Expertise in 21 CFR Part 11
• Experienced in validating manufacturing automation solutions including MES, SCADA, PLC, Data Historians, EBR
• 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

• Medical device or regulated industry experience strongly preferred.
• ASQ SQE (Software Quality Engineer) certification
• Familiarity with 21 CFR 820 a plus

Responsibilities

• 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
• Improves systems and processes that improve product safety; increase product consistency and conformance to requirements; improve production efficiency; reduce operating and scrap costs

What This Job Offers

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