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MES Engineer

San Diego, CA


Responsibilities
  • The MES Engineer will translate process requirements and MES system best practices into practical, usable electronic batch records.
  • Develop design requirements, functional specifications, and support computer system validation strategy.
  • Participate in the development of global standards for batch record design, integration with process/test equipment and other electronic business and automation systems.
  • Provide leadership to a cross-site, multi-functional collaboration to implement MES.
  • Partner with internal departments & external vendors to assist in commissioning MES system.
  • Relocation. $130K-$180K.


Requirements
  • The MES Engineer will have a BS degree and 10+ years experience in pharma, biotech or cell therapy industry.
  • 5+ years of cGMP regulations. Knowledge of cell culture or cell therapy manufacturing technical support.
  • Knowledge and application of ANSI/ISA-88 (process control) and ANSI/ISA-95 (automated interfaces) standards.
  • Good Automated Manufacturing Practice (GAMP) framework for risk-based approach to computer system validation.
  • 2+ years of experience with Werum PAS-X MES a plus.
  • Must be legally eligible to work in the U.S. and have a stable work history. Sponsorship is not available.







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