Drug Substance Electronic Batch Record Expert
6 days ago
As a Sr Software Engineer at Aditi Consulting in Thousand Oaks, you will play a vital role in supporting our Drug Substance Supply organization. This manufacturing support role requires expertise in electronic batch record generation, validation, and communication between GMP operations teams and process development scientific groups.
The ideal candidate will possess a strong understanding of Client-X software, GMP environments, and bioprocessing. They will also demonstrate excellent teamwork and communication skills, as well as the ability to apply continuous improvement tools to drive Lean Transformation.
Responsibilities:
- Generate electronic documentation and track NPI/EBR metrics
- Validate new Electronic Batch Records (Application Lifecycle Management)
- Assist in implementing new MES functionality (Equipment Management (EQM), PCS MBR Elements)
- Develop standard work and business practices for new MES functionality
- Contribute to Lean Transformation through recording NPI/EBR metrics and applying continuous improvement tools
- Extensive experience with Client-X software for electronic batch records
- Strong operations knowledge of drug substance manufacturing and bioprocessing
- Excellent teamwork and communication skills
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