Ian Wallis

About Ian Wallis

About:Eliminating and controlling cleanroom contamination is my professional passion. I am an industry leader delivering critical solutions for product and process protections. I manage the delivery of precision cleaning & disinfection services, comprehensive contamination control training and ISO 14644/14698 GAP Analysis Audits.• Clean Technology Expert Witness in the New England Compounding Disaster in Framingham, MA• Editor of the International Standard, ISO 14644-5 Cleanroom Operations and Associated Controlled Environments.• Federal Standards Writer and Voting Committee Member with the Institute of Environmental Sciences and Technology (IEST), Contamination Control (CC) Working Groups on Recommended Practices (RP’s) for Cleanroom Environments.• Participated in many FDA and international regulatory audits• Managed and participated in the cleaning of sensitive NASA projects.• Performed surface particle studies to measure the relative cleanliness of vacuuming vs tacky rolling.• Nilfisk Global design committee member seeking improvements to the ubiquitous Model GM 80 HEPA Filtered Vacuum, that resulted in the new GM 80CR-GMP/ULPA.• Contributor to the Parenteral Drug Association’s (PDA) Technical Report on Cleaning and Disinfection.Over the past thirty years, I have had experience with more than two hundred (200) clients, including forty-eight (48) Fortune 500 cleanroom manufacturers in the Pharmaceutical, Biotech, Medical Device, Medical, Aerospace, Semiconductor and Nanotech Industries.As Director of Quality Operations at CleanTech:• I administer our Quality Management System (QMS)• Manage our Comprehensive Modular Training Program• Manage our detailed Transition & Start-Up Planning • Manage new account Start-Up’s with a focus on leading, coaching, training, OJT, inspections, and customer guidance and feedback.• Participate in Business Development

Experience

1. Director of Quality Operations

   Cleantech Systems, Inc

   Dec 2021 — Present · Danvers, MA, US

   Our service solutions include but are not limited to:• Ongoing Cleanroom Cleaning & Disinfection Services• Consultation Services for Managing the Risk of Contamination• Federal and International Standards (ISO 14644) GAP Analysis Audits• Comprehensive Cleanroom & Protocol Training• Customized SOP Writing• Interstitial and Plenum Cleaning• Covid-19 Exposure Disinfecting Services*Professional Janitorial Services for our Cleanroom CustomersWe add value to our customers by working with them as strategic partners focused on quality protections. This maximizes their profit margins, while at the same time satisfies the strict demands of the federal and international regulatory agencies.In order to be successful, we must be aligned with our customer’s quality programs and manufacturing schedules. At CleanTech we leverage subject matter expertise, extensive industry knowledge and a companywide scalable training and operating model. Working together with our customers, we strive for continuous improvement to deliver the highest quality Contamination Control Services possible.

Education

• University of Massachusetts at Amherst

  Bachelor's degree, School of Humanities

  1980 — 1984

Skills

• Business Strategy
• Troubleshooting
• Contamination Control
• Cleaning Validation
• Expert Witness
• Iso 14644-5 Cleanroom Operations
• Sop Writing
• Biotechnology
• Clean Rooms
• 21 Cfr Part 11
• Capa
• Gmp
• Biopharmaceuticals
• Cleanroom Quality Manufacturing
• Regulatory Gap Analysis