Stephanie White

WORK HISTORY

EDUCATION

SKILLS

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.