This role provides daily technical support to cGMP manufacturing operations including process monitoring and issue resolution
Job Summary
This role provides daily technical support to cGMP manufacturing operations including process monitoring and issue resolution.
The successful candidate will partner with cross-functional teams to investigate deviations, perform root cause analysis, and implement corrective actions.
Key responsibilities include supporting process transfer, validation activities, and ensuring audit readiness in a regulated environment.
Matching Summary
This role provides daily technical support to cGMP manufacturing operations including process monitoring and issue resolution.
Skills & Requirements
Must-have
GMP compliance and documentation
Process troubleshooting and validation
Cross-functional team collaboration
Deviation investigation and CAPA
Technical writing for protocols
Nice-to-have
Lean continuous improvement tools
Cell culture media experience
SAP MES LIMS system familiarity
Customer audit support experience
Scale-up and tech transfer background
Key Requirements
Bachelor's degree in Life Sciences or related field
Minimum 5 years of biopharmaceutical manufacturing experience
Hands-on GMP documentation and validation experience