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Senior Engineer

2 months ago

Cambridge, Massachusetts, United States Vedanta Biosciences Inc Full time
About the Role

The Senior Process Engineer will be responsible for working cross-functionally to design, scale, and implement processes in Vedanta's manufacturing facilities. This individual is a motivated and experienced process engineer and will focus on operations support, project execution, and tech transfer.

Key Responsibilities
  • Process Validation: Support Process Validation activities including protocol and report authoring, review, and execution.
  • Process Development: Assist process development with wet lab work performed as part of the FMEA pre-PV. Hands-on approach to gain understanding of the current process to be validated, in preparation for protocol development.
  • Tech Transfer: Lead tech transfers within a multiple manufacturing site enterprise in support of high throughput/demand.
  • Quality Assurance: Support PAI preparation and inspection.
  • Documentation: Develop standardized documentation including SOP's, training, validation of equipment, and reports.
  • Project Management: Be a part of project teams in developing project and technology transfer strategy for both clinical and commercial manufacturing campaigns, including process validation and associated regulatory filings.
  • Leadership: Drive results on multiple complex assignments, in addition to reviewing and guiding the work and performance of vendors/consultants.
Requirements
  • Education: Engineering degree or equivalent required.
  • Experience: 5+ years of engineering experience in a biomanufacturing or development environment with 4+ years in a GxP environment preferred.
  • Skills: Excellent interpersonal and communication skills (verbal and written) are required. Expected to be able to present own work to peers and cross-functional managers and influence decisions. Technical writing skills required.
  • Desirable: Prior PV work highly desired.