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 are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law.

Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship. Where necessary, we disclose salary ranges for roles in all countries in which we operate.

The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits.

For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/ . For other locations, additional information will be provided during the recruitment process.

If you have any questions, please speak with your recruiter. Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position. Salary Range (annually) $62,355.00 - $128,700.00