We are currently looking to add a Cleanroom & HEPA Certification Specialist to our growing team. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our Cleanroom & HEPA Certification Specialist will support our manufacturing by coordinating the performance of preventive maintenance and on-demand work of certification activities.
As a Cleanroom & HEPA Certification Specialist, a typical day might include the following:
- Planning and scheduling outside contractors/vendors to perform scheduled and/or non-scheduled PM or general work
- Working with Certification Vendor(s) and Regeneron 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
This role might be for you if you:
- Are comfortable and have the flexibility to work in a changing environment
- Have experience with electronic work record systems (Blue Mountain Regulatory Asset Manager preferred but not required)
- Have gowning experience for entering and working on Cleanroom environments
- Have experience in Cleanroom, ISO Classifications, HEPA Filtration or HVAC Systems, or equivalent combination of education and experience
- Seek to build and maintain positive working relationships with the business
- Possess strong written and verbal communication skills
- Maintain effective time management skills to allow timelines to be met in a timely manner
- Have knowledge of Microsoft Office Suite and overall comfort and general familiarity with computer systems
To be considered for the Cleanroom & HEPA Certification Specialist position you should have a BA/BS degree, preferably in an Engineering or Construction Technologies related area and the following minimum amounts of experience for each level:
- Associate Specialist: 0+ years of experience or equivalent combination of education and experience.
- Specialist: 2+ years of relevant experience, including experience with CMMS and experience in HEPA Filtration or HVAC Systems, or equivalent combination of education and experience.
- Senior Specialist: 5+ years of relevant experience, including experience with CMMS and experience in HEPA Filtration or HVAC Systems, or equivalent combination of education and experience.
Prior experience in Cleanroom and HEPA Certification or HVAC preferred.
Level will be determined based on qualifications relevant to the role.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually)
$58,480.40 - $124,300.00
Top Skills
What We Do
At Regeneron we believe that when the right idea finds the right team, powerful change is possible. As we work across our expanding global network to invent, develop and commercialize life-transforming medicines for people with serious diseases, we’re establishing new ways to think about science, manufacturing and commercialization. And new ways to think about health. Connect with us so we can learn more about you, and you can learn more about our biopharmaceutical medicines. And join us, as we build a future we believe in.
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