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
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 in Cleanroom environments
Have experience in Cleanroom, ISO Classifications, HEPA Filtration or HVAC Systems
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 must have a BA/BS degree, or equivalent combination of education and experience, preferably in an Engineering or Construction Technologies related area and the following minimum amounts of relevant experience, including experience with CMMS and experience in HEPA Filtration or HVAC Systems, for each level:
Specialist: 2+ years
Senior Specialist: 5+ years
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 step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.
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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
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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. Please visit www.regeneron.com/social-media-terms for information on how to engage with us on social media. An important note about privacy: Regeneron is committed to your privacy and will not ask for sensitive personal information such as social security number, date of birth or bank account details via email or social media.
