Stephanie White

About Stephanie White

Providing transformative solutions for engineering project delivery is my passion! With over 20 years of experience in the pharmaceutical and biotech industry, I specialize in commissioning, qualification, and validation, helping companies define strategies and solutions that provide the best value.My greatest strength lies in developing relationships and leveraging my creative and technical capabilities to help organizations truly transform. As a Senior Manager of Engineering Projects and Global Lead for Validation, I focus on creating efficient and effective strategies to enhance project delivery, by working with vendors and cross-functional teams.I collaborate with cross-functional engineering teams to define project requirements and identify critical data for project delivery. These ongoing efforts aim to integrate data across functional groups, resulting in more efficient and effective project delivery. This integrated data approach helps to better define the scope of work, provide benchmarks for robust budget estimation, establish resourcing strategies, and ensure projects are delivered on time and within budget.Successes in my career include using data analytics to improve engineering project delivery processes, ensuring consistency across sites, and providing accurate budget estimations and activity tracking. I am committed to implementing simple and efficient transformative processes that deliver the best value to the company.Professional Highlights:Implemented a global risk-based C&Q program to standardize engineering and validation activities, increasing efficiency and effectiveness.Established a global Community of Practice to share knowledge and best practices across the network effectively.Successfully managed large capital projects, consistently meeting all milestones and budgets.Collaborated on regulatory submissions for several drug products, resulting in successful commercial licensing.Competencies:LeadershipCommunicationEngineering system designFacilities, equipment, and computer validation (PCS, MES, BMS, PLC)Project managementChange control managementGlobal quality and complianceRegulatory submission writingEU and US-FDA regulatory inspection supportData integrityI am dedicated to providing transformative solutions and look forward to helping your company achieve its goals.

Experience

1. Cqv and Operational Readiness Lead

   A-BIO

   Aug 2025 — Present · Wilmington, NC, US

   I am currently the Computer System Validation Project Manager and Technical Lead for the Sterile Fill and Formulation Manufacturing Project at Quality Chemical Laboratories. I provide leadership and technical support for the computerized system qualification for embedded PLC/HMI and SCADA system for critical utilities (WFI, PS, and PW), supporting equipment (parts washer, parts autoclave, and terminal sterilizer), and sterile filling equipment (filling lines, lyophilzer, and isolators).

Education

• University of Wisconsin-Madison

  Master's in Engineering Managment, Engineering/Industrial Management

  2015 — 2017

• North Carolina State University

  BS, Electrical Engineering

• San Diego State University

  MS, Biomedical Quality Systems

  2008 — 2010

• The University of North Carolina at Chapel Hill

  BA, Education

Skills

• Capa
• Visio
• Gamp 5.0
• Eudralex Volume 4
• Computer System Validation
• Automation
• Pharmaceutical Industry
• Sop
• Fda
• Biotechnology
• 21 Cfr
• Six Sigma
• Gxp
• Ms Project
• Agile Project Management
• Verification and Validation (V&V)
• Quality System
• Gamp
• Testing
• Lims
• 21 Cfr Part 820
• Gmp
• Equipment, Facility, and Utility Validation
• Corrective and Preventive Action (Capa)
• Standard Operating Procedure (Sop)
• Astm
• U.s. Food and Drug Administration (Fda)
• Manufacturing
• Laboratory Information Management System (Lims)
• Quality Assurance
• U.s. Title 21 Cfr Part 11 Regulation
• 21 Cfr Part 211
• Validation
• Change Control
• Technology Transfer
• Astm E2500
• 21 Cfr Part 11