MSAT Associate Principal Engineer
Core
Lead process transfer, process support, and continuous improvement for commercial biopharmaceutical manufacturing operations.
Role type
Senior IC manufacturing science and technology engineer (process transfer & support)
Builds
Robust and reliable commercial manufacturing processes for biologics
Domain
Biopharmaceutical manufacturing / Chemical Engineering
Required skills
process transfer, root cause analysis, deviation investigations, GMP compliance, technical writing, cross-functional leadership, change control assessment, data interpretation, structured problem-solving
Preferred skills
advanced biopharmaceutical manufacturing technologies, customer-facing technical support, regulatory audit participation
Technologies
cGMP regulations, quality systems, commercial biologics manufacturing operations
Responsibilities
Lead process transfer and process support activities for commercial manufacturing processes; Provide technical leadership to cross-functional teams to address complex manufacturing and product quality challenges; Evaluate process changes and major deviations for impact on manufacturing performance; Conduct advanced root cause investigations and lead implementation of corrective and preventive actions; Interface directly with customers through technical committees to provide updates and support; Author and review technical documentation and support change control assessments.
Seniority
Senior, hands-on IC
