- Manufacturing Electronic Batch Record (EBR) generation using PAS-X (Korber)
- Validation of new Electronic Batch Records (Application Lifecycle Management)
- Assisting in implementation of new MES functionality
- Develop standard work and business practices for new MES functionality
- Contributing to Lean Transformation through recording NPI/EBR metrics and application of continuous improvement tools.
- Participate and contributing to projects to introducing new products and/or advancement of new manufacturing technologies into the plant.
- Experience with PAS X (Korber) software for electronic batch records with detailed understanding of editing and validation
- Strong knowledge of PAS-X integration with external programs (SAP, PI, and DeltaV)
- Strong operations knowledge of drug substance manufacturing and a broad understanding of related disciplinary areas in bioprocessing
- Demonstrated ability to work in a team
- Degree in Chemical Engineering, Biochemistry, Chemistry or Biology or Computer Science with experience in biotechnology
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System Engineer - Thousand Oaks, United States - EPITEC
Description
This is a manufacturing support role responsible for the generation of electronic documentation, for tracking of NPI/EBR metrics, and for communication between the GMP operations teams and the process development scientific groups.
Job scope and responsibilities:
Preferred Qualifications: