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.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and 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. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually)