Summary:
In this vital role you will be a part of the company, 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 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 the 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 in and contributing to projects to introduce new products and/or advancement of new manufacturing technologies into the plant.

Day to Day 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.
• Participating in and contributing to projects to introduce 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

Must Have Skill Sets:

• Must be very experienced in Client-X
• Integration with external programs is also a requirement
• Experience with Client X (Korber) software for electronic batch records with detailed understanding of editing and validation
• Strong knowledge of Client-X integration with external programs (SAP, PI, and Delta V)
• Strong operations knowledge of drug substance manufacturing and a broad understanding of related disciplinary areas in bioprocessing

Compensation:
The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on several factors, including but not limited to, a candidate's qualifications, skills, competencies, experience, location and end client requirements).
Benefits and Ancillaries:
Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions.
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