MSAT Engineer - Tech Transfer & Process Support

Regeneron Pharmaceuticals, Inc.; United States; Remote; USD 62,000 - 92,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a skilled professional to support technology transfer activities across internal and external sites. You will help create process descriptions, master plans, and technical reports, while reviewing batch records and automation recipes.

The role uses engineering principles to solve manufacturing problems, analyze data, and drive continuous improvement. On-site collaboration with cross-functional teams is essential to ensure timely, compliant execution.

Qualifications

• 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.

Responsibilities

• Support internal and external technology transfer activities, including 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 SAT 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.

Skills

Biopharma manufacturing knowledge

Engineering reasoning

cGMP & data integrity

Data analysis & communication

Cross-functional collaboration

Prioritization & time management

Job description

Regeneron Pharmaceuticals, Inc. is seeking a skilled professional to support technology transfer activities across internal and external sites. You will help create process descriptions, master plans, and technical reports, while reviewing batch records and automation recipes.

The role uses engineering principles to solve manufacturing problems, analyze data, and drive continuous improvement. On-site collaboration with cross-functional teams is essential to ensure timely, compliant execution.