Facilities Compliance Specialist (Technical Writer) at Regeneron Pharmaceuticals, Inc.

We are currently looking to fill a Facilities Compliance Specialist (Technical Writer) position. 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.

*This is an onsite position located in Rensselaer, NY*

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

• 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
• Facilitating reviews and revisions of Facilities Department related Standard Operating Procedures, Work Instructions, Risk Assessments, and OJT Task Evaluations for each group within the Department
• Managing and providing support, information, and assistance to individuals and groups with the initiation, review, submission, and follow-up of documents such as Change Controls and Corrective and Preventive Action plans
• Participating in, and obtaining results of, all Facilities Department quality and regulatory audits.

• Have extensive technical writing experience in a manufacturing environment, pharmaceutical industry preferred
• Can prioritize multiple assignments and changing priorities in a fast-paced environment
• 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+ years
• Specialist: 2+ years
• Senior Specialist: 5+ years

May substitute relevant experience in lieu of educational requirements. 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)