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

• 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 Bachelors 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 Regenerons roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regenerons on-site policy and expectations for your role and your location., Regeneron is a leading biotechnology company that invents, develops, and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.