This role supports manufacturing operations by providing daily technical assistance, process monitoring, and issue resolution in a cGMP environment
Job Summary
This role supports manufacturing operations by providing daily technical assistance, process monitoring, and issue resolution in a cGMP environment.
The successful candidate will lead validation activities, manage deviations with root cause analysis, and drive continuous improvement to enhance yield and efficiency.
Candidates must possess strong technical writing skills to prepare SOPs, work instructions, and reports while collaborating with cross-functional teams including Quality and Engineering.
Matching Summary
This role supports manufacturing operations by providing daily technical assistance, process monitoring, and issue resolution in a cGMP environment.
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
Data analysis for process optimization
Key Requirements
Bachelor's degree in Life Sciences or related field
Minimum 5 years of relevant biopharma experience
Hands-on GMP documentation and validation experience