Sr Engineer - Software - Calsoft Labs
Thousand Oaks, CA 91320
About the Job
Local to ATO is preferable but can be remote
Sr Engineer - Manufacturing Execution System (MES)
In this vital role you will be a part of the Client, Thousand Oaks, Drug Substance Supply organization. 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. This position will be focused Electronic Batch Records for Drug Substance manufacturing.
Job scope and responsibilities:
" Manufacturing Electronic Batch Record (EBR) generation using Client-X (Korber)
" Validation of new Electronic Batch Records (Application Lifecycle Management)
" Assisting in implementation of new MES functionality (Equipment Management (EQM), PCS MBR Elements)
" 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.
Preferred Qualifications:
" Skilled with Client X (Korber) software for electronic batch records with detailed understanding of GMBR design
" Experience with validation of GMBRs in a GMP environment
" Knowledge of Client-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
Sr Engineer - Manufacturing Execution System (MES)
In this vital role you will be a part of the Client, Thousand Oaks, Drug Substance Supply organization. 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. This position will be focused Electronic Batch Records for Drug Substance manufacturing.
Job scope and responsibilities:
" Manufacturing Electronic Batch Record (EBR) generation using Client-X (Korber)
" Validation of new Electronic Batch Records (Application Lifecycle Management)
" Assisting in implementation of new MES functionality (Equipment Management (EQM), PCS MBR Elements)
" 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.
Preferred Qualifications:
" Skilled with Client X (Korber) software for electronic batch records with detailed understanding of GMBR design
" Experience with validation of GMBRs in a GMP environment
" Knowledge of Client-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
Source : Calsoft Labs
