The Sr. MES Engineer is a key member of the Engineering Services Organization. In this role, the position will assist in Requirements gathering, technical proposals, design and development of complex MES (Manufacturing Execution Systems) projects for the Facility which is a FDA Regulated production site.
The position will act as the technical lead, as well as an individual contributor on facility projects, contributing to system architecture design, development of electronic procedures, and integration with local and enterprise systems. Perform high level technical analysis activities, such as requirements gathering and performing gap analysis of user requirements against software functionality as well as defining MES solution architectures and developing detailed design specifications
Define functional requirements through client interviews, documentation analysis and Work Flow Process Mapping along with the development of Electronic Procedures
Work with Process Controls and I.T. organizations regarding the development and implementation of System interfaces.
This position ensures MES implemented Manufacturing/Quality organizations by providing trouble shooting services, issue resolution, root cause analysis, and pro-active preventative procedures.
Provide expert knowledge and experience to estimate the technical effort and cost required to implement complex MES solutions as well as proactively reporting on project progress against schedules
Actively participate on technical and business project teams, ensuring that effective relationships are built and maintained being responsible for technical deliverables during the entire lifecycle of MES solution development projects
This position is responsible for ensuring cGMP/Regulatory compliance with internal/external policies, guidelines; these include internal SOP's, departmental standards and conventions.
Acts as liaison with Global communication and coordination with other CSL sites in the development and implementation of Strategic projects as related to MES.
This position interacts with external organizations, consultants and vendors as required in the successful accomplishment of project assignments.
This position is responsible for the development of Project Plans, timelines, cost estimates, project strategies, and associated tracking and reporting.
Position Qualifications and Experience Requirements: Provide hiring requirements for the specified position, including educational, experiential, and competency requirements necessary for the position.
Education
Bachelor's Degree: preferably in Computer Science, MIS, Engineering, Operations, Business, or equivalent knowledge
Experience
- 2 – 6 years industry experience in systems or process development, programming, process automation, Operations, or engineering discipline
· 4 - 6 years' experience working within MES applications (Manufacturing Execution Systems)
- Experience with one or more of the following systems a plus – Werum, Syncade,Invensys, POMSnet,Camstar, Elan designing or implementing MES applications
- Preferred Pharma/Biotech industry experience
Competencies
Standard Microsoft Office and Productivity tools,
S88/S95 General principals
MES Software, Interfaces to DCS/OPC, ERP, LIMS, Document Management required.
Advanced understanding of business and manufacturing logistics.
Strong exposure to MES technologies, including automated data collection, historian applications (OSI PI a plus). SCADA, automated decision control, workflow, database applications, and interface to ERP and LIMS systems
Exposure to enterprise level large-scale applications