Cleanroom & HEPA Certification Specialist

Role Summary

Cleanroom & HEPA Certification Specialist. Coordinate preventive maintenance and on-demand certification activities to support manufacturing. Ensure timely certifications of HEPA-filtered areas and equipment, maintain records, and contribute to program enhancements.

Responsibilities

• Planning and scheduling outside contractors/vendors to perform scheduled and/or non-scheduled PM or general work
• Working with Certification Vendor(s) and Facilities, Manufacturing and Lab Management Scheduling Groups to ensure timely certifications of HEPA filtered areas and equipment
• Recording certification activities in electronic records
• Ensuring safe and efficient maintenance of all Cleanroom and HEPA supplied equipment and related support equipment with strict adherence to SOPs, cGMPs, and quality standards
• Being responsible for vendor documentation files, including hardcopy and electronic formats
• Collecting, trending and analyzing HEPA Filter data
• Identifying areas for improvement and implementing proactive program enhancements
• Participating as a Subject Matter Expert (SME) in the creation and revision of Procedures and Work Instructions and supporting Regulatory and Partner Audits as a SME

Qualifications

• Required: BA/BS degree or equivalent combination of education and experience, preferably in Engineering or Construction Technologies related area
• Experience with CMMS and HEPA Filtration or HVAC Systems
• 2+ years for Specialist; 5+ years for Senior Specialist
• Prior experience in Cleanroom and HEPA Certification or HVAC preferred
• Gowning experience for entering and working in Cleanroom environments
• Experience with electronic work record systems (Blue Mountain Regulatory Asset Manager preferred but not required)
• Strong written and verbal communication skills
• Effective time management to meet timelines
• Knowledge of Microsoft Office Suite and general computer proficiency

Skills

• Cleanroom operations and ISO classifications
• HEPA filtration, HVAC systems
• Vendor management and scheduling
• Documentation control and recordkeeping
• Data trending and analysis
• Procedures and work instruction development
• Regulatory and internal audit support

Education

• Bachelor‚Äôs degree (preferred in Engineering or Construction Technologies) or equivalent combination of education and experience
• Specialist: 2+ years; Senior Specialist: 5+ years of relevant experience