Lauren Evrard

About Lauren Evrard

I am a driven, thorough engineer who executes with integrity and purpose. I work to develop a variety of perspectives to better myself as a team member, citizen, and well-rounded employee. I am constantly growing and exploring ways to apply my skillset and expand myself.I strive to proactively improve processes, analyze methods, and construct custom solutions to better the field and business output. I work with life sciences companies and am well-versed in validation and regulatory guidance. I am specialized in consulting with clients to implement digital validation solutions, as well as provide validation services and project management.

Experience

1. Director of Commissioning, Qualification, and Verification (Cqv) Digital Transformation

   Arc Technologies Group

   Dec 2020 — Present · US

   Implemented digital CQV platform Kneat Gx for FDA-regulated top-10 life sciences client to transition from paper processes to fully electronic system Developed proprietary templates, lifecycle flows, and project packages to streamline GxP qualification activities across departments and disciplines Worked alongside global team and sites worldwide to align on system rollout, discuss restrictions and risk management, and design original approaches for consistency and alignment Generated extensive technical SOPs, WIs, and training material, ensuring robust compliance with regulatory, company, and site directives while incorporating system nuances Hosted weekly project meetings to discuss priorities, roadblocks, updates, and client expectations Built business cases for system use expansion along with templates Provided product support, training, and restrospectives to evaluate system use and system upgrades Completed full validation lifecycle for several projects within the Kneat Gx platform (with focus on computer systems, equipment, and lab instruments) Performed Change Management procedures and managed non-conformances Collaborated with and transitioned between multiple cross-functional teams as responsibility structure changed, priority projects shifted, and client staff were reallocated Drafted SOWs, time estimations, and project proposals to pitch areas of improvement; worked with potential new clients and partnerships to expand ATG\'s CQV offering

Education

• Purdue University

  Bachelor of Science (BS), Industrial Engineering

Skills

• Microsoft Access
• Minitab
• Plant Layout
• Industrial Engineering
• Food
• Qualification Development
• Simio
• Equipment Qualification
• Eams
• Microsoft Office
• Gmp
• Validation
• Autocad
• Pdoc
• Microsoft Project
• Visio
• Management
• Microstrategy Reporting
• Change Management
• Teamwork
• Quality Tracking System (Gts)
• Qualification Testing