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Software Engineer

2 months ago

Thousand Oaks, United States EPITEC Full time

We are seeking a skilled Sr. Engineer to join our leading biotechnology client's Drug Substance Supply organization in Thousand Oaks. This pivotal role focuses on Electronic Batch Records (EBRs) for Drug Substance manufacturing and involves generating electronic documentation, tracking NPI/EBR metrics, and facilitating communication between GMP operations teams and process development scientific groups.


Key Responsibilities:

  • EBR Generation: Create and manage Electronic Batch Records using PAS-X (Korber).
  • Validation: Validate new Electronic Batch Records within Application Lifecycle Management.
  • Implementation Support: Assist in the rollout of new MES functionalities, including Equipment Management (EQM) and PCS MBR Elements.
  • Process Development: Develop standard work and business practices for new MES functionalities.
  • Lean Transformation: Record NPI/EBR metrics and apply continuous improvement tools to drive Lean Transformation.
  • Project Participation: Contribute to projects introducing new products or advancing new manufacturing technologies in the plant.


Preferred Qualifications:

  • Software Expertise: Proficient with PAS-X (Korber) software and a detailed understanding of GMBR design.
  • Validation Experience: Proven experience validating GMBRs in a GMP environment.
  • Integration Knowledge: Familiarity with PAS-X integration with external programs such as SAP, PI, and DeltaV.
  • Industry Knowledge: Strong operational knowledge of drug substance manufacturing and a broad understanding of related bioprocessing areas.
  • Team Collaboration: Demonstrated ability to work effectively within a team setting.
  • Educational Background: Degree in Chemical Engineering, Biochemistry, Chemistry, Biology, or Computer Science with relevant experience in biotechnology.