Senior Associate Process Engineer, MSAT

ElevateBio • Waltham, MA

3d

About The Position

ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization. We have integrated a differentiated set of technologies, end-to-end services, and industry-leading manufacturing expertise to develop advanced therapies faster and more efficiently. The Role: ElevateBio is looking for a Senior Associate Process Engineer within Manufacturing Technology and Sciences organization. As a Senior Associate Process Engineer in Manufacturing Science and Technology, you will provide technical support for GMP manufacturing including support for Visual Inspection (VI) Program, Deviation and Investigation, Change Control and CAPA implementations and continuous improvement projects within a highly matrixed cross functional team for Base Camp programs. As part of support, you will write protocols, product impact assessments, root-cause analysis reports, technical reports. You will support data collection and charting for non-GMP and GMP batches.

Requirements

• Bachelor’s Degree in Life Sciences, Engineering, or a related technical discipline, or equivalent experience
• 3+ years of experience in a MSAT, manufacturing or process development role
• Experience in cell and gene therapy, aseptic processing, or parenteral drug product inspection preferred
• Strong communication skills and ability to work cross-functionally with technical and quality teams
• Familiarity with electronic systems used in GMP environments such as Veeva, or electronic batch records

Responsibilities

• Work cross-functionally across Manufacturing, Quality and Supply Chain to provide support for cGMP manufacturing for both clinical and commercial stage programs across modalities including cell and gene therapy, mRNA and viral vector.
• This individuals focus areas would include support for Visual Inspection program.
• Own and maintain VI related documents
• Maintain VI qualification program including kits and training.
• Monitor and analyze VI related data and own data review meeting and annual data report.
• Own VI related deviations, investigations, product impact statement and related CAPAs
• Work closely with Tech Transfer teams to implement VI program for new program introductions
• Authoring and reviewing technical documentation related to manufacturing activities including protocols, technical reports, work instructions, SOPs.
• Own and support quality events such as deviations, investigations, CAPA, Change Control.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior