Engineer, Manufacturing Engineer

Hybrid – 2-3 days onsite per week. Flexibility for more onsite requirements may be necessary.

Ideal candidate: B.S. and 2

YOE in Pharma. Nice to have:
Drug product experience

As a member of the process development team, this role will be focused on identifying and developing aspects of drug product to advance process design for parenteral drug products. The candidate will perform experiments, organize data and analyze results with minimal supervision. The candidate will establish the experimental design, develop and implement protocols, obtain reproducible and reliable results, analyze data and communicate results to cross‑functional groups.

• Supports the establishment of robust tactical and strategic objectives related to visual inspection
• Supports ongoing development in the area of visual inspection (i.e. development and maintenance of defect panels, establishment of GMP procedures related to operations)
• Implements and documents off‑line and on‑site drug product characterization studies
• Author and/or own high‑quality process technology transfer and other technical documents
• Participate in cross‑functional teams working effectively in a highly matrixed team environment to drive change, efficiency, and strong relationships
• Provide ongoing support to clinical and commercial fill/finish manufacturing operations through troubleshooting, root‑cause analysis, and product impact assessments for non‑conformance investigations and process changes/improvements
• Design, execute and document primary data packages related to drug product design and process development, and communicate key findings in presentations
• Support one or more clinical and commercial process introductions or process transfers into Client manufacturing network

• 2+ years of experience within the pharmaceutical/biotechnology industry
• Experience in development/characterization of aseptic fill/finish unit operations (freeze/thaw, mixing, sterile filtration, filling, stoppering, visual inspection, etc.) to define critical process parameters
• Organizational, technical problem solving, communication (written and verbal) skills, and regular interactions
• Ability to learn and act on dynamic information at a rapid pace
• Familiar or ability to learn to use electronic record keeping, GMP, laboratory notebooks, statistical analysis and software
• Strong knowledge of quality systems and drug product manufacturing
• Experience in a matrix team environment and interacting with Analytical Sciences, Process Development, Project Management, Manufacturing, Regulatory, Compliance, and/or Quality
• Capable of organizing and communicating complex technical concepts to enable business decisions