Engineer I, MSAT
Core
Process Engineer providing process science support for GMP manufacturing, technology transfers, development studies, characterization, and validation within a cross-functional team.
Role type
Process Engineer (Manufacturing Science and Technology)
Builds
Drug product manufacturing processes and systems
Domain
Biotechnology / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP manufacturing, aseptic processing, cell culture, process development, process validation, lifecycle management, deviation resolution, root cause analysis, technical writing, data analysis, statistical process controls
Preferred skills
LOVO, Sepax, Rotea, CliniMACs devices, automated fillers, Certified Quality Engineer, Six Sigma Green Belt, Six Sigma Black Belt
Technologies
LOVO, Sepax, Rotea, CliniMACs, automated fillers
Responsibilities
Provide technical SME support for troubleshooting issues during cGMP manufacturing; Author and review technical documentation including protocols, batch records, SOPs, and regulatory submissions; Execute experiments and perform data analysis to resolve process deviations; Support gap analyses and risk assessments for capital projects and tech transfers; Assist in execution of Process Validation activities; Identify and propose continuous process improvements to enhance performance, robustness, and efficiency; Participate in evaluation of new technology and process automation for GMP manufacturing.
Seniority
Mid-Senior, hands-on IC
