Change Control Specialist — GMP & CAPA Champion

Regeneron Pharmaceuticals, Inc.; City of Rensselaer (NY); On-site; USD 62,000 - 129,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking multiple Change Control Specialist roles in Rensselaer, NY.

The positions involve developing strategic change control plans, implementing CAPAs, and ensuring GMP-compliant documentation across manufacturing operations. Roles require a Life Sciences/Engineering background with progressive experience levels, and they emphasize cross-functional leadership, risk assessment, and collaboration with senior leadership.

Qualifications

• BS/BA in Life Sciences, Engineering, or related field.
• 0-2+ years of relevant experience for Associate level.
• 2+ years of relevant experience for Change Control Specialist.
• 5+ years of relevant experience for Senior Change Control Specialist.

Responsibilities

• Craft business plans to independently advance change control initiatives to implement CAPAs and process improvements.
• Assess proposed change controls to evaluate if proposal satisfies company standards.
• Coordinate and prepare change control documentation assessing scope, impact, risk, and regulatory impact.
• Review, edit, and revise controlled documentation in accordance with cGMP standards.
• Coordinate and/or lead cross-functional meetings to drive change control implementation.
• Provide advice and mentorship to cross-functional teams to enable GMP compliant change controls.
• Independently monitor and progress multiple projects, addressing obstacles in a timely manner.
• Present critical and regulatory impactful change controls to senior leadership; document all training.
• Assist with training of new employees.

Skills

Change control

CAPA

Documentation

Education

BS/BA in Life Sciences or Engineering

Job description

Regeneron Pharmaceuticals, Inc. is seeking multiple Change Control Specialist roles in Rensselaer, NY.

The positions involve developing strategic change control plans, implementing CAPAs, and ensuring GMP-compliant documentation across manufacturing operations. Roles require a Life Sciences/Engineering background with progressive experience levels, and they emphasize cross-functional leadership, risk assessment, and collaboration with senior leadership.