Associate MSAT Engineer

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 oSAT 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.

Requirements

• 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.

Benefits

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits.

Pay

Salary Range (annually): $62,355.00 - $92,400.00 (Canada)