Position Summary

The Lead HEPA Certification Technician will provide direct leadership to the HEPA certification team, represents the team for site wide HEPA Certification requirements, guides and mentors both technicians and Engineers in HEPA Certification practices and principles.

Essential Duties and Responsibilities:

• Provides direct leadership to HEPA certification technicians
• Acts as Subject Matter Expert (SME) for HEPA certification sitewide needs
• Provides support to cross functional workstreams in development of appropriate measurement methods, including implementation of new methods, analyzing existing measurement methods, and executing training as required
• Lead, develop, and support measurement methods in compliance with regulations (ISO 14644, EU Annex 1)
• Administration of HEPA testing assets
• Contributes to continuous process improvement efforts to reduce scrap, cycle times, improve efficiency, and eliminate waste.
• Conforms with and abides by all regulations, policies, work procedures, instructions, and safety rules.
• Plans and schedules work

Knowledge, Skills, Abilities

• Strong instrumentation and HEPA certification experience
• Proficient use of Asset Management and Quality Systems
• Strong understanding of industrial instrumentation HVAC, and measurement principals
• Ability to read and understand electrical schematics, loop diagrams, and P&IDs.
• Ability to work hours necessary to support shift production
• Good troubleshooting skills; ability to analyze and diagnose pressure trends and HEPA certification failures
• Demonstrates good organizational skills and high attention to details including following

good manufacturing practices (CGMPs) and good documentation practices (GDPs)

• Understanding of GMP/GLP, ISO 14664, IEST, and EU Annex 1 Standards, Guidelines, and practices.
• Demonstrated ability to work in a team environment
• Must have the ability to author and review accurate and effective Standard Operating Procedures or work instructions
• Proficient with Microsoft Office (Word, Excel, PowerPoint, Project)
• Ability to lift 50 lbs. unassisted

Experience Requirements

Education Requirements

Associate’s degree or equivalent experience in related field.