Sr Engineer - Software
The Judge Group Inc.

Location: REMOTE
Salary: $65.00 USD Hourly - $80.00 USD Hourly
Description:
Our client is currently seeking a Sr Engineer - Software

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 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.

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

Basic Qualifications

Doctorate Degree OR Master Degree and 3 years of Engineering experience OR Bachelor Degree and 5 years of Engineering experience

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

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.

Contact: akeshari@judge.com

This job and many more are available through The Judge Group. Find us on the web at www.judge.com

---