David Doyel

About David Doyel

Validation / Quality Engineer with 18 years of experience in FDA, EU, and ISO–regulated environments, including pharmaceutical drug, medical device, and vitamin supplement manufacturingProven leader of cross-functional teams and validation projects, supporting product launches, remediation efforts, and compliance recovery across multiple organizationsSpecialized in Equipment and Process Validation, with hands-on expertise in IQ/OQ/PQ protocol authoring and executionAuthor of Final Validation Summary Reports and complete validation packagesExtensive experience writing, reviewing, and revising SOPs, specifications, and quality technical documentationStrong ability to interpret, review, and revise engineering drawings to support validation and compliance activities

Experience

1. Senior Staff Validation Engineer (Engineer 5)

   Flex

   Oct 2022 — Present · Austin, TX, US

   On staff subject matter expert for all quality and validation concerns regarding Facilities and Utility Systems for the manufacturing of Diabetic Testing medical devices as a contract manufacturer. Systems include Clean Room Qualifications, Compressed Dry Air Systems, Central Vacuum Systems, and Environmental Monitoring Systems (EMS). Work with more junior level colleagues and cross functional teams to ensure successful validation of the utility systems that support all of the sites medical manufacturing businesses. Involved in document reviews, audits, NCMRs and CAPAs among other responsibilities.

Education

• California State Polytechnic University-Pomona

  Bachelor's of Science, Biotechnology w/ Chemistry Minor

  2001 — 2007

• Sultana High School

  Diploma

  1999 — 2001

Skills

• Laboratory Technicians
• Protocol
• Iso 13485
• Pharmaceutical Industry
• Fda
• 21 Cfr
• Fmea
• Change Control
• Technical Writing
• Design Control
• Capital Equipment
• Microsoft Office
• Iso 14971
• Sterilization
• Regulatory Affairs
• Sanization
• Gmp
• Validation
• European Union
• Installation Qualification
• Operational Qualification
• U.s. Food and Drug Administration (Fda)
• Design of Experiments
• Process Improvement
• Sop Development
• Medical Devices
• Capa
• Quality System
• V&V
• Performance Qualification
• Cleaning Validation
• Deviations
• Processes Development
• Biomedical Engineering
• Clean Rooms
• 21 Cfr Part 11