Facilities Compliance Specialist (Technical Writer)

Regeneron Pharmaceuticals • Rensselaer, NY

3d • Onsite

About The 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 role involves facilitating the creation, review, and revision of various compliance documents, acting as a liaison between departments, and managing non-compliance issues to ensure timely resolution in accordance with company procedures and regulatory requirements. The position also supports the development of CAPAs and owns Change Controls, assisting with the initiation, review, submission, and follow-up of related documents. Participation in quality and regulatory audits and potential oversight of contractors are also key aspects of this role.

Requirements

• Technical writing experience in a manufacturing environment, pharmaceutical industry preferred
• Ability to prioritize multiple assignments and changing priorities in a fast-paced environment
• Experience with Veeva
• Knowledge of CFR Part 11 and conformance requirements for data integrity
• Knowledge of regulations pertaining to asset maintenance, cleaning and operational control, asset lifecycles, Annex 11 regulations
• Understanding of equipment and terminology used in a manufacturing operation
• Organized and have an attention to detail
• Bachelor’s degree
• Associate Specialist: 1+ year relevant experience
• Specialist: 2+ years relevant experience
• Senior Specialist: 5+ years relevant experience

Nice To Haves

• Excel in a collaborative, cross functional environment

Responsibilities

• 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

Benefits

• 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
• Paid leaves (e.g., military and parental leave)

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level