Associate MSAT Engineer

Regeneron Pharmaceuticals•Valley, AL

4d•$62,355 - $92,400•Onsite

About The Position

Provides manufacturing science and technology (MSAT) support for internal and/or external manufacturing operations across multiple modalities. Supports technology transfer, process validation, and ongoing manufacturing support activities to ensure processes are implemented, operated, and maintained in a compliant and reliable manner.

Requirements

BS/BA in an engineering discipline or equivalent combination of education and experience.
2+ years of relevant experience in a pharmaceutical/biologics cGMP manufacturing, MSAT, process development, or analytical environment (for Engineer level).
5+ years of relevant experience (for Sr Engineer level).
4+ years of relevant experience (for Sr Engineer level with MS).
0-2 years of relevant experience (for Sr Engineer level with PhD).
Knowledge of biopharmaceutical manufacturing processes and technology transfer principles.
Ability to apply engineering principles to evaluate process and product behavior and to develop defensible conclusions.
Familiarity with cGMP requirements, data integrity principles, and regulated documentation practices.
Ability to analyze and interpret manufacturing and analytical data; communicate findings clearly in written and verbal formats.
Strong collaboration skills and ability to work effectively in cross-functional and cross-site environments.
Ability to manage multiple priorities and deliver high-quality outputs within timelines.

Responsibilities

Support internal and external technology transfer activities, including participation in facility fit assessments and high-level gap assessments.
Generate, review, and support documentation associated with technology transfer, including process descriptions, master plans, reports, and technical documents.
Provide technical support to manufacturing operations during start-up, engineering runs, validation, and routine manufacturing.
Leverage engineering principles during problem solving and process support.
Review manufacturing documentation generated by receiving sites, including batch records, automation recipes, SOPs, and change documentation.
Gather, trend, and analyze process data to support process understanding and ongoing process performance monitoring.
Participate in investigations and deviation assessments and support identification of root causes and corrective actions.
Apply engineering principles to the development and execution of manufacturing support activities.
Analyze data using a combination of statistics, engineering principles and other techniques to gain insight into manufacturing support activities.
Work effectively in cross-functional teams to support timely execution of MSAT deliverables.
Ensure activities are performed in accordance with cGMP.
May lead others.
Perform other duties as assigned.
Travel to internal manufacturing sites or external partners as required (<10% to 50%).