Cleanroom & HEPA Certification Specialist

Role Summary

Cleanroom & HEPA Certification Specialist responsible for coordinating preventive maintenance and on-demand certification activities to support manufacturing operations.

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 adherence to SOPs, cGMPs, and quality standards
• Managing 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 an SME

Qualifications

• Required: BA/BS degree or equivalent combination of education and experience, preferably in Engineering or Construction Technologies related area
• Specialist: 2+ years of relevant experience; Senior Specialist: 5+ years
• Experience with CMMS and HEPA Filtration or HVAC Systems
• Experience with electronic work record systems (Blue Mountain Regulatory Asset Manager preferred but not required)

Skills

• Strong written and verbal communication skills
• Ability to work in a changing environment
• Time management skills to meet timelines
• Proficiency with Microsoft Office Suite and general computer systems
• Gowning experience for entering and working in Cleanroom environments

Education

• BA/BS degree or equivalent; relevant experience in Engineering/Construction Technologies; CMMS and HEPA/HVAC experience preferred