Facilities Compliance Specialist - Technical Writing

We are currently looking to fill a Facilities Compliance Specialist (Technical Writing) 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*

In this role, a typical day might include the following:

• Acts as a liaison between the Facilities Department and onsite quality and regulatory groups to define and address all issues of non-compliance

• Manage and participate 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

• Facilitate reviews and revisions of Facilities Department related Standard Operating Procedures, Work Instructions, Risk Assessments, and OJT Task Evaluations for each group within the Department

• Manage and provides 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

• Participates in, and obtain results of, all Facilities Department quality and regulatory audits.

This role might be for you if:

• Have extensive technical writing experience in a manufacturing environment, pharmaceutical industry preferred

• You can prioritize multiple assignments and changing priorities in a fast-paced environment

• You have an understanding of equipment and terminology used in a manufacturing operation

• You are organized and have an attention to detail

• You 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 – 0-2 years

• Specialist - 2 years

• Sr Specialist – 5 years

May substitute relevant experience in lieu of educational requirements. Level is determined based on qualifications relevant to the role.