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Cleanroom & HEPA Certification Specialist

Regeneron Pharmaceuticals, Inc.
Rensselaer, New York
Start date
Sep 28, 2022

View more

Clinical, Clinical Medicine
Required Education
Bachelors Degree
Position Type
Full time
Pharm Country, Best Places to Work
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Job Details

Cleanroom & HEPA Certification Specialist (Rensselaer, NY)

Regeneron Pharmaceuticals, Inc. is seeking a Cleanroom & HEPA Certification Specialist (Rensselaer, NY) to oversee the preparation and approvals of pre-work documentation specific to certification process (permission to work forms, checklists, etc.). Manage relationships with Certification Vendors. Work with Certification Vendors and Regeneron Facilities, Manufacturing, and Lab Management Scheduling Groups to ensure timely certifications of HEPA filtered areas and equipment. Oversee the completion of HEPA Filter certification activities performed by Certification Vendors. Record certification activities in electronic records.  Ensure a safe work environment is maintained through adherence to safety guidelines and policies. Review vendor certification documentation. Manage training requirements and ensure completion of vendor training within the required timeline.  Manage vendor documentation files, including hardcopy and electronic formats. Collect, trend, and analyze HEPA Filter data. Identify areas for improvement and implement proactive program enhancements. Participate as a Subject Matter Expert in the creation and revision of Procedures and Work Instructions. Support Regulatory and Partner Audits.

Job Requirements:

Requires a Bachelor’s degree (or foreign equivalent) in Mechanical Engineering or related field and 2 years of Cleanroom Certification experience. Must have the following experience: CMMS Electronic Work Record database; Record Review (electronic and hard copy); Quality Review / Oversight / Trend Reports; HEPA Filtered Systems and Controls; Cleanroom and ISO / EU Classifications; Metrology / Instrumentation; Cleanroom Gowning Experience; and Pharmaceutical Operations.

Per Executive Order, Regeneron requires all U.S. employees to be fully vaccinated against COVID-19, unless they are legally entitled to an accommodation for medical or religious reasons.

Apply at, reference code R13674.



Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

Stock Symbol: REGN

Stock Exchange: NASDAQ

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Find Us
Corporate Headquarters
777 Old Saw Mill River Road
New York
United States
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