- 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.
- 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.