Specialist Manufacturing
Core
Support manufacturing/quality systems including non-conformances, process validation, procedures, training, and new product introductions for bioprocessing operations.
Role type
Specialist Manufacturing (Process Support)
Builds
Bioprocessing unit operations and GMP production processes
Domain
Life Sciences / Bioprocessing / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP production operations, bioprocessing unit operations, process validation, non-conformance management, CAPA execution, regulatory compliance, technical writing, process monitoring, change control
Preferred skills
CAPA EV, developing new procedures, enhancing current processes, implementing new processes, modifying SOPs, training operators
Technologies
Control charting
Responsibilities
Initiate, revise, and approve manufacturing procedures; assess process performance and implement improvements; triage non-conformances and author investigation reports; assist with process validation protocols and execution; participate in regulatory inspections; support new product introductions and equipment modifications.
Seniority
Individual Contributor, Specialist