Senior System Engineer Job at Planet Pharma, Thousand Oaks, CA

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  • Planet Pharma
  • Thousand Oaks, CA

Job Description

Ideal Candidate: 5-10 years of experience.

• Manufacturing Execution System (Kroeber PAS|X) designer / validation experience - Candidates should be SME's in this

• Experience with Enterprise Resource Planning (SAP) software

• Experience with biotech manufacturing (Drug Product process)

Job scope and responsibilities:

  1. Manufacturing Electronic Batch Record (EBR) generation using PAS-X (Korber)
  2. Validation of new Electronic Batch Records (Application Lifecycle Management)
  3. Assisting in implementation of new MES functionality (Equipment Management (EQM), PCS MBR Elements)
  4. Develop standard work and business practices for new MES functionality
  5. Contributing to Lean Transformation through recording NPI/EBR metrics and application of continuous improvement tools.
  6. Participate and contribute to projects to introducing new products and/or advancement of new manufacturing technologies into the plant.
  7. Engage with the rest of the network to assess EBR differences and identify path forward toward higher-effectiveness way-of-working.

Basic Qualifications:

Master’s degree and 4 years of MES experience Or

Bachelor’s degree and 6 years of MES experience Or

Associate’s degree and 10 years of MES experience Or

High school diploma / GED and 12 years of MES experience

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, DeltaV, Rockwell)
  • Strong operations knowledge of drug product manufacturing and a broad understanding of related disciplinary areas in bioprocessing
  • Demonstrated ability to work in a distributed team
  • Demonstrated ability to manage project deliverables and proactively engage with project stakeholders
  • Degree in Chemical Engineering, Bioengineering, Biochemistry, Chemistry or Biology or Computer Science with experience in biotechnology

Pay Range: $60-71/hr

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