MES Engineer

Job Title: Sr Engineer - Software/MES Engineer

Location: Thousand Oaks, CA

Duration: 12+ Months

Description:

Job scope and responsibilities:

• 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 (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 PAS X (Korber) software for electronic batch records with detailed understanding of GMBR design

• Experience with validation of GMBRs in a GMP environment

• 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