Change Control Specialist

Regeneron Pharmaceuticals•Rensselaer, IN

1d•$62,355 - $128,700•Onsite

About The Position

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking to fill multiple Change Control Specialist positions. These positions develop strategic plans related to change control and the implementation of robust corrective actions to support manufacturing operations by applying function expertise. Current Departments with Openings: Bulk Drug Substance Manufacturing, Technical Operations, Fill/Finish Manufacturing.

Requirements

BS/BA in Life Sciences, Engineering, or related field; or equivalent combination of education and experience
0-2+ years of relevant experience (for Associate Change Control Specialist)
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 Corrective and Preventative Actions (CAPA’s) and process improvements in support of manufacturing operations
Assess sophisticated proposed change controls to evaluate if proposal satisfies company standards
Coordinate and prepare change control documentation that assesses and defines the scope, impact, risk, and regulatory impact associated with the change
Review, edit, and revise controlled documentation in accordance with cGMP standards
Coordinate and/or lead cross-functional meetings with multiple departments to drive change control implementation
Provide advice and mentorship to cross-functional teams to enable successful and GMP compliant change controls
Independently monitor and progress multiple projects concurrently – identifying, addressing, and/or raising potential obstacles in a timely manner
Present business critical and regulatory impactful change controls to senior leadership
Document all training
Assist with the training of new employees