GMP Change Control Specialist

Regeneron; City of Rensselaer (NY); On-site; USD 62,355 - 128,700; Full time

Job summary

Regeneron in Rensselaer, NY is seeking Change Control Specialists to develop plans for CAPAs and process improvements supporting manufacturing operations. You will assess proposed changes, determine regulatory impact, and coordinate comprehensive change controls documentation.

You will lead cross‑functional meetings, mentor teams for GMP‑compliant controls, and manage multiple projects while presenting to senior leadership. On‑site work model with competitive rewards.

Qualifications

• BS/BA in Life Sciences, Engineering, or related field, or equivalent experience.
• Experience in change control processes and CAPA in manufacturing environments.
• Ability to coordinate cross-functional teams and prepare technical documentation.
• Familiarity with cGMP standards and regulatory impact assessment.

Responsibilities

• Develop plans to advance change control initiatives and CAPAs.
• Assess proposed change controls against company standards.
• Coordinate documentation covering scope, risk, and regulatory impact.
• Lead cross-functional meetings to drive change implementation.
• Mentor teams for GMP-compliant change controls.
• Monitor multiple projects concurrently and address obstacles.
• Present critical change controls to senior leadership.
• Document training and assist with onboarding new employees.

Skills

Change control

CAPA implementation

Cross-functional coordination

Regulatory compliance

Education

BS/BA in Life Sciences, Engineering, or related field

Equivalent combination of education and experience

Job description

Regeneron in Rensselaer, NY is seeking Change Control Specialists to develop plans for CAPAs and process improvements supporting manufacturing operations. You will assess proposed changes, determine regulatory impact, and coordinate comprehensive change controls documentation.

You will lead cross‑functional meetings, mentor teams for GMP‑compliant controls, and manage multiple projects while presenting to senior leadership. On‑site work model with competitive rewards.