Facilities Compliance Specialist (Technical Writer)

We are currently looking to add a Facilities Compliance Specialist (Technical Writer) 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 Facilities Compliance Specialists ensure cGMP compliance for the Facilities Management Department.

As a Facilities Compliance Specialist, a typical day might include the following:

• Facilitating creation, review and revision of Facilities Department related Standard Operating Procedures, Work Instructions, Risk Assessments, and ILCs, Job Aids  for each group within the Department
• Acting as a liaison between the Facilities Department and onsite quality and regulatory groups to define and address all issues of non-compliance
• Managing and participating in Facilities Department issues of non-compliance to ensure all activities related to the investigation and resolutions of non-conformities are performed in a timely manner and in compliance with Regeneron procedures and regulatory requirements
• Supporting development of CAPAs
• Owning Change Controls
• Managing and providing support, information, and assistance to individuals and groups with the initiation, review, submission, and follow-up of documents related to  Change Controls and Corrective and Preventive Action plans
• Participating in, and obtaining results of, all Facilities Department quality and regulatory audits
• May oversee contractors

This role might be for you if you: 

• Have technical writing experience in a manufacturing environment, pharmaceutical industry preferred
• Can prioritize multiple assignments and changing priorities in a fast-paced environment
• Have experience with Veeva
• Have knowledge of:
  • CFR Part 11 and conformance requirements for data integrity
  • Regulations pertaining to asset maintenance, cleaning and operational control, asset lifecycles,
  • Annex 11 regulations
• Have an understanding of equipment and terminology used in a manufacturing operation
• Are organized and have an attention to detail
• Excel in a collaborative, cross functional environment 

To be considered for this role you must hold a Bachelor’s degree and the following minimum amounts of relevant experience for each level:

• Associate Specialist: 1+ year
• Specialist: 2+ years
• Senior Specialist: 5+ years

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