Cleanroom & HEPA Certification Specialist

Role Summary

We are currently looking to add a Cleanroom & HEPA Certification Specialist to our growing team. This role supports our manufacturing by coordinating preventive maintenance and on-demand certification activities for cleanrooms and HEPA-related systems, ensuring adherence to SOPs, cGMPs, and quality standards.

Responsibilities

• Planning and scheduling outside contractors/vendors to perform scheduled and/or non-scheduled preventive maintenance or general work
• Collaborating with Certification Vendors and Facilities, Manufacturing, and Lab Management Scheduling Groups to ensure timely certifications of HEPA-filtered areas and equipment
• Recording certification activities in electronic records
• Maintaining safe and efficient operation of Cleanroom and HEPA equipment and related support equipment in line with SOPs and quality standards
• Managing vendor documentation files (hardcopy and electronic)
• Collecting, trending, and analyzing HEPA filter data
• Identifying areas for improvement and implementing proactive program enhancements
• Serving as a Subject Matter Expert in the creation and revision of Procedures and Work Instructions and supporting regulatory and partner audits as an SME

Qualifications

• Required: Comfortable working in a changing environment; strong written and verbal communication skills; effective time management; proficient with Microsoft Office Suite and computer systems
• Preferred: Experience with electronic work record systems (Blue Mountain Regulatory Asset Manager preferred but not required)
• Preferred: Gowning experience for entering and working in Cleanroom environments
• Preferred: Experience in Cleanroom, ISO Classifications, HEPA Filtration or HVAC Systems

Skills

• Vendor coordination and scheduling
• Documentation management and record-keeping
• Data collection, trending, and analysis
• Procedures and Work Instructions development and revision (SME)

Education

• BA/BS degree, or equivalent combination of education and experience, preferably in an Engineering or Construction Technologies related area
• Experience levels (with CMMS and HEPA Filtration or HVAC Systems) determine level: Associate (1+ year), Specialist (2+ years), Senior Specialist (5+ years)