Cleanroom & HEPA Certification Specialist

BioSpace; Town of East Greenbush (NY); On-site; USD 66,400 - 126,800; Full time

Benefits offered by this job

Health and Wellness Programs

Annual Bonuses

Paid Time Off

Job summary

BioSpace is actively seeking a Cleanroom & HEPA Certification Specialist for its facility in East Greenbush, NY. This role involves planning maintenance schedules, ensuring compliance with safety standards, and collaborating with vendors to uphold certification processes in biopharmaceutical manufacturing. Ideal candidates will have a relevant educational background and experience in cleanroom environments, as well as strong communication skills to support effective maintenance and certification activities.

Qualifications

• Minimum of 2 years of relevant experience.
• Experience with HEPA Filtration or HVAC Systems.
• Familiarity with electronic work record systems.

Responsibilities

• Plan and schedule contractors for maintenance tasks.
• Record certification activities in electronic records.
• Ensure adherence to SOPs and quality standards.

Skills

Communication Skills

Time Management

Flexibility

Education

BA/BS Degree in Engineering or Construction Technologies

Tools

CMMS

Microsoft Office Suite

Job description

Cleanroom & HEPA Certification Specialist

Join to apply for the Cleanroom & HEPA Certification Specialist role at BioSpace

Cleanroom & HEPA Certification Specialist

12 hours ago Be among the first 25 applicants

Join to apply for the Cleanroom & HEPA Certification Specialist role at BioSpace

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 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, Preferably In An Engineering Or Construction Technologies Related Area And The Following Minimum Amounts Of Experience For Each Level

• 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 step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, 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. 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.

Salary Range (annually)

$66,400.00 - $126,800.00

Seniority level

• Seniority level

  Entry level

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