Principal MSAT Engineer

Role Overview

Provide support for internal and/or external manufacturing operations across multiple modalities. Support technology transfer, process validation, and ongoing manufacturing support activities to ensure processes are implemented, operated, and maintained in line with compliance.

Key Responsibilities

• Provide key technical expertise for internal and external technology transfer of drug substance manufacturing processes for products utilizing synthetic chemistry, mainly peptides
• Generate, review, and support documentation associated with technology transfer and lifecycle activities, 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
• Work effectively in multi-functional teams (e.g., Manufacturing, Quality, Regulatory, Analytical Sciences, Engineering) to support timely execution of MSAT tasks
• Ensure activities align with cGMP standards, data integrity expectations, and applicable safety standards
• Identify potential technical risks and raise issues with proposed mitigation strategies
• Lead defined workstreams for technology transfers or process validation activities, including coordination of cross-functional inputs
• Provide technical mentorship to junior engineers
• Own and maintain detailed transfer gap assessments and execution plans for sophisticated processes or programs
• Define and justify risk-based approaches for process validation, control strategies, and change implementation

Required Qualifications

• BS/BA degree in an Engineering related field, with proven experience or equivalent combination of education and experience
• Principal Engineer: BS/BA in engineering field with 8+ years of proven experience; MS with 7+ years; or PhD with 2 years of experience
• Staff Engineer: BS/BA with 10+ years of experience and demonstrated cross-site scientific leadership; MS with 9+ years; PhD with 5+ years of experience; or equivalent combination of education and experience

Preferred Qualifications

• BS in Chemical Engineering or Biochemical Engineering
• Knowledge of biopharmaceutical manufacturing processes and technology transfer principles
• Familiarity with cGMP requirements, data integrity principles, and regulated documentation practices