Principal Investigator

Sanofi•Pearl River, NY

17h•Onsite

About The Position

This position is within the Protein Sciences Manufacturing group and will support Manufacturing Operations by completing deviation investigations. The candidate will work cross-functionally with various support groups to implement effective and preventative actions as well as perform a thorough product impact assessment. This is a 1st shift position. Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster. About Sanofi We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Requirements

High School Diploma and 3+ years’ cGMP experience.
Associates Degree and 2+ years’ cGMP experience
Bachelor’s degree and 1+ years’ cGMP experience

Nice To Haves

Must have knowledge of continuous improvement techniques and problem-solving skills.
Previous experience working within a production department of a pharmaceutical company preferred.
The candidate must be able to work extended and flexible hours (including weekends) when needed.

Responsibilities

Authoring and resolution of deviations, change controls, CAPAs, or documents in order to meet production and product release requirements.
Identification and facilitation of interdepartmental process improvements.
Utilize root cause analysis techniques during deviation investigational process
Work cross-functionally, to develop and implement continuous process improvements
Support production needs and continuous improvement including change control, deviation writing/review, CAPA implementation, and operational optimization.
Write, review, revise and prepare manufacturing documents (BPR, SOP, WI) in accordance with cGMP and regulatory guidelines.
Communicate across multiple groups and levels to obtain consensus in order to facilitate deviation closure
Manage multiple priorities either independently or as part of a team in order to meet key deadlines and communicate issues and progress across all levels of the organization
Accurately communicate (both written and verbal) progress and updates across multiple levels of the organization and regulatory agencies.