Associate MSAT Engineer

About the Role

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.

Key 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%).

Requirements & Tech Stack

• 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.
• 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.