Title: MES Engineer
Experience: 7-15 YOE
The ideal candidate must have knowledge of bioprocess manufacturing and be responsible for the design, implementation and validation of MES systems. Implementation expertise in all the following project phases: Requirements documentation, detailed design generation, implementation, system integration, testing, commissioning and on-site startup.
Responsibilities:
- Design, configuration, integration and implementation of MES solutions for Pharma and Biotech industries.
- Work with manufacturing and other plant personnel to gather requirements to implement recipe level control under the S-88 and S-95 standards.
- Develop functional and detailed design requirements, configure, program and implement MES systems; validate Syncade and PAS/X implementations.
- Design and implement interfaces to systems such as LIMS, ERP, EDMS.
- Develop Software and Hardware Design Specifications.
- Develop and execute validation/testing protocols.
Qualifications:
- BS/MS in Chemical, Electrical, Mechanical Engineering or equivalent degree
- Experience with large scale biologics operations in a cGMP manufacturing environment is required
- Experience in plant start up, equipment commissioning, and shakedown is a plus
- Must have direct experience in cGMP operations