Cleanroom And HEPA Certification Specialist Jobs In Japan

A global biopharmaceutical company that manufactures life saving therapeutics is seeking a Cleanroom and HEPA Certification Specialist to join their growing team. This role is perfect for someone who enjoys coordinating certification activities, working with outside vendors, and ensuring that cleanroom environments meet strict quality standards. You will plan and schedule preventive maintenance and on demand work for HEPA filtered areas and equipment, record certification activities in electronic systems, and trend filter data to identify areas for improvement. If you have a BA or BS degree in Engineering, Construction Technologies, or a related field, plus one to five years of relevant experience, this specialist position offers a clear career path from Associate to Senior Specialist based on your qualifications. You will work onsite in a cGMP environment, so gowning experience and comfort with cleanroom protocols are essential. This is not a remote role; you will be at the heart of manufacturing operations that supply patients worldwide with approved therapeutic proteins and clinical study materials.

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Company Overview

The employer is Regeneron, a leading biotechnology company that discovers, develops, and manufactures medicines for serious diseases. Regeneron is known for its innovative approach and commitment to quality. The company has an inclusive culture and provides comprehensive benefits including health and wellness programs, fitness centers, a 401k company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves for eligible employees. Regeneron operates state of the art manufacturing facilities that adhere to strict cGMP and quality standards. Working here means being part of a team that values safety, efficiency, and continuous improvement. The Rensselaer, New York facility is one of their key manufacturing sites. This is not a small startup; it is a well established company with a global reach and a mission to bring powerful medicines to patients.

Key Responsibilities

Plan and schedule outside contractors and vendors to perform scheduled and non scheduled preventive maintenance or general work on cleanroom and HEPA systems
Work with certification vendors and Regeneron Facilities, Manufacturing, and Lab Management scheduling groups to ensure timely certifications of HEPA filtered areas and equipment
Record certification activities in electronic records, maintaining accurate and audit ready documentation
Ensure safe and efficient maintenance of all cleanroom and HEPA supplied equipment and related support equipment with strict adherence to standard operating procedures, cGMPs, and quality standards
Manage vendor documentation files, including hardcopy and electronic formats, for easy retrieval during inspections
Collect, trend, and analyze HEPA filter data to identify performance patterns and potential issues
Identify areas for improvement and implement proactive program enhancements to increase reliability
Participate as a Subject Matter Expert in the creation and revision of procedures and work instructions, and support regulatory and partner audits

Qualifications

A BA or BS degree or equivalent combination of education and experience is required, preferably in an Engineering or Construction Technologies related area. Experience with a Computerized Maintenance Management System is required. Experience in HEPA Filtration or HVAC Systems is required. For Associate level, one plus years of relevant experience. For Specialist level, two plus years. For Senior Specialist level, five plus years. Prior experience in cleanroom and HEPA certification or HVAC is preferred. You must be comfortable with gowning for entering and working in cleanroom environments. Experience with electronic work record systems, particularly Blue Mountain Regulatory Asset Manager, is preferred. Strong written and verbal communication skills are essential. Effective time management and familiarity with Microsoft Office Suite are expected. You must be comfortable working in a changing environment and building positive working relationships. US work authorization is required. Level will be determined based on qualifications.

Benefits and Perks

This full time position offers an annual salary range of USD 62,355 to USD 128,700 depending on your level and experience. You will work onsite at a Regeneron facility. Benefits include health and wellness programs covering medical, dental, vision, life, and disability insurance. You have access to fitness centers. The company provides a 401k company match, family support benefits including parental leave, equity awards, annual bonuses, paid time off, and paid leaves for military or parental reasons. Professional development opportunities are available. The inclusive culture supports work life balance. Relocation assistance may be available depending on the role level.

How to Apply

To apply for this Cleanroom and HEPA Certification Specialist position, visit the Regeneron careers website and search for the job posting. Submit your resume and cover letter highlighting your relevant experience with HEPA filtration or HVAC systems. Shortlisted candidates will be contacted for an interview. If this role matches where you want to take your career, do not wait. Qualified candidates should apply as soon as possible.

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