MES Consultant in Devens, MA
- Title: MES Consultant
- Code: RCI-50553-1
- Location: Devens, MA 01434
- Posted Date: 10/04/2022
- Duration: 12 Months
- Name:Anthony Blomer
- Email: firstname.lastname@example.org
- Phone: 908-704-8843 ✖
Client is looking for local candidates
However if you find a very strong candidate who is willing to relocate at their own expense
- 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.
Required Competencies Knowledge, Skills, And Abilities
- Ability to effectively communicate with both technical and non-technical team members.
- Strong interpersonal skills, especially regarding
- Teamwork and collaboration
- Client focus
- 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:
- Bachelor’s 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.
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