Visual Inspection Associate Program Manager

Regeneron Pharmaceuticals, Inc.; Town of East Greenbush (NY); Presencial; USD 120.000 - 180.000; Jornada completa

Descripción de la vacante

Regeneron is seeking a Visual Inspection Associate Program Manager to lead the site’s visual inspection program for liquid and lyophilized injectable products. The role ensures inspection standards, regulatory compliance, equipment performance, and technological innovation across manufacturing operations.

Responsibilities include overseeing defect classification, KPI monitoring, cross-functional collaboration with Manufacturing, QA, Regulatory, and Process Development, and evaluating

Formación

• Bachelor's in scientific or engineering field with 6+ years of manufacturing experience, including supervisory roles in cGMP fill/finish environments.
• Experience with visual inspection programs and regulatory standards (USP, EU Annex 1, CFR 211, ICH/PDA).

Responsabilidades

• Oversee inspection standards, defect classification, and defect library development.
• Monitor KPIs to drive continuous improvement.
• Collaborate cross-functionally with Manufacturing, QA, Regulatory, and Process Development.
• Evaluate emerging inspection technologies including automation and AI/ML.
• Manage and develop the technical team while maintaining cGMP and GDP compliance.

Conocimientos

Visual inspection program leadership

Cross-functional collaboration

Regulatory compliance awareness

Data-driven decision making

Educación

Bachelor's in science or engineering

Herramientas

AI inspection tech

Descripción del empleo

Role:

Visual Inspection Associate Program Manager leading the site’s visual inspection program for liquid and lyophilized injectable products at Regeneron.

Objectives:

ensure inspection standards, regulatory compliance, equipment performance, and technological innovation.

Responsibilities:

• oversee inspection standards, defect classification, and defect library development
• monitor KPIs to drive continuous improvement
• collaborate cross-functionally with Manufacturing, QA, Regulatory, and Process Development
• evaluate emerging inspection technologies including automation and AI/ML
• manage and develop the technical team while maintaining cGMP and GDP compliance

Qualifications:

• Bachelor's in scientific or engineering field with 6+ years of manufacturing experience, including supervisory roles in cGMP fill/finish environments
• experience with visual inspection programs and regulatory standards (USP, EU Annex 1, CFR 211, ICH/PDA)

Preferred:

• ownership of inspection programs, regulatory compliance, and familiarity with automated/AI inspection tech

High-Value:

biologics manufacturing, fill/finish stage, cGMP regulated environment, focus on inspection technology innovation.

Work setup:

on-site in Rensselaer, NY.