Jessi Done

Jessi Done is a seasoned regulatory executive and microbiologist with over 20 years of multidisciplinary experience spanning the medical device, pharmaceutical, food, and biotech industries. She currently serves as Senior Director of Microbiology & Sterilization at Eurofins Medical Device Services US, where she leads strategic and operational initiatives across multi-site laboratory and sterilization functions. In this role, Jessi is responsible for advancing innovation, ensuring regulatory compliance, and accelerating growth by integrating cutting-edge technologies with client-focused, consultative support for medical device manufacturers. In this role, Jessi is focused on driving innovation, operational excellence, and strategic growth—helping manufacturers navigate complex regulatory environments, optimize microbiological testing, and accelerate time-to-market through advanced technologies and consultative support.

In parallel, she continues her long-standing work as an Independent Regulatory & Microbiological Consultant through Brainard Environmental, LLC and Pivot Lab Innovation, LLC. Her consulting expertise includes:

ISO regulatory and quality management systems (QMS)
Sterilization validation and compliance (ethylene oxide, thermal processing, aseptic techniques)
Contamination control and facility design for CDMOs (including EU Annex 1)
Air quality compliance and APEN calculations for environmental regulatory submissions
Expert witness services supporting litigation in the medical device and pharmaceutical sectors
Food safety and SQF consulting, including HACCP programs, aseptic systems, and thermal process controls

Jessi brings a deep understanding of aseptic processing, sterilization technologies, and regulatory frameworks (FDA, ISO, EPA, OSHA, and international standards), enabling organizations to achieve compliance, enhance product safety, and scale operations with confidence. Jessi is a frequent contributor to technical and regulatory discussions, including committee participation with AAMI and other standards organizations.

Her previous executive experience includes serving as Vice President of Sterilization Services at Terumo Blood and Cell Technologies, where she led a full-service ethylene oxide sterilization facility, oversaw more than $42M in capital improvements, and built high-performing teams that delivered consistent revenue growth and regulatory excellence. She also played a key role in operations management, communications, government relations, and site-wide compliance efforts.

Jessi holds an MBA in Contract Management and Sales Development and a BS in Microbiology, with additional concentrations in chemistry, zoology, and legal studies. She is a Registered Microbiologist (NRCM), Certified Six Sigma Green Belt, ISO 13485 Auditor, Thermal Process Authority, and holds numerous certifications in food safety, quality systems, aseptic processing, and OSHA compliance.

With a proven track record of success in technical operations, regulatory strategy, risk management, and quality systems, Jessi is passionate about helping companies across highly regulated industries achieve excellence in microbiology, sterilization, business operations optimization and regulatory compliance.

Whether leading multi-site laboratory teams, building new sterilization platforms, or consulting on contamination control and facility readiness, she brings unmatched dedication, technical depth, and a collaborative spirit to every project.