Description

About the job
Location: Thousand Oaks, CA or Remote

Duration: 12 months (Possible extension)

REMOTE CANDIDATES MUST HAVE PAS X EXPERIENCE*****************

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 on 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
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

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

Top 3 Must Have Skill Sets

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

Integration with external program is also a requirement

Day To Day 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
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.

Key Skills
Education

Any Graduate

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