Our client, a leading pharmaceutical company, is hiring a MES Consultant on a contract basis.
MES Engineer – Cell Therapy Manufacturing Systems supports the successful operation of the Devens Cell Therapy Manufacturing Execution System (MES) . Reporting into a fast growing IT organization this individual will be responsible for identifying and driving solutions related to the Devens Cell Therapy MES system. This will include designing, building, testing and documenting of solutions and will require a high level of understanding of MES systems and attention to detail. This individual will also be responsible for the development and adherence of MES & IT system governance procedures.
• Ability to effectively communicate with both technical and non-technical team members.
• Strong interpersonal skills, especially regarding
o Teamwork and collaboration
o Client focus
o Verbal and written communication
• Knowledge of industry standard integration protocols and programming applications such as OPC, ODBC, SQL and Web API.
• Knowledge and experience with MES, preferably Emerson Syncade.
• Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, and good documentation practices.
• Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment that support Biologics and clinical manufacturing.
• Strong technical and problem-solving skills and the ability to work independently.
• Demonstrated success working in a high-performing, business results-driven environment.
• Familiarity with Business Intelligence (BI) and reporting programs including InfoBatch, Crystal Reports, Spotfire, Tableau or similar tools.
• Understanding of computer system validation.
Education And Experience:
• Bachelors degree in an engineering or MIS discipline.
• Must have experience with MES, preferably Emerson Syncade, in a bio-tech manufacturing environment.
• Must have 5+ years of hands-on experience in a biotech manufacturing and supply chain environment.
• Understanding of supply chain, manufacturing domains and supporting technology including manufacturing and supply chain ERP systems (e.g. Oracle, SAP).
• Working knowledge of regulatory requirements and how they relate to existing and new business systems and practices, primarily GxP.
• Sound understanding of Electronic Batch Records (EBR) and Review by Exception (RBE).
• Must have prior experience working on a project team to implement, customize, or enhance an MES system.
Duties And Responsibilities:
• Collaborate with business stakeholders and implementation partner(s) to configure, build, and deploy the MES and other Enterprise IT systems.
• Collaborate with business process leads to design master data, recipes, etc.
• Provide support for operationalizing the manufacturing and peripheral systems.
• Accountable for uninterrupted 24/7 operation of manufacturing systems for CAR-T manufacturing.
• Support daily operation and future enhancements of MES and lower-level systems as an IT system owner and technical expert.