Mes Engineer
1 day ago
The person will provide expertise with the MES system to enhance a digital, integrated shop floor. The person will also help establish standards and templates for eBRs as required.
**_Responsibilities include:
- **
- Production:
- Responsible for ensuring MES and potentially other manufacturing related computerized systems are available to support Operations Schedule Adherence requirements.
- Managing small projects related to MES and ensuring that the appropriate controls, approvals, and validation requirements are implemented
- Training /Deviations /Compliance:
- Ensuring that Process, Equipment and Automation documentation is compliant and inspection ready.
- Participating in inspections conducted by external regulators
- Partnering with direct and indirect management chain to ensure the following:
- Assisting with Department Training Plan and supporting execution.
- Ensuring Inspection Readiness of assigned areas
- Assisting completion of investigations and deviations.
- Continuous Improvement:
- Working collaboratively with inter-department and cross-functional teams to support necessary changes in a timely and productive manner
- Identifying opportunities to improve manufacturing processes and practices
- Ensuring all manufacturing management tools/systems and documentation (SOPs, MBR's, OJTs) is accurate
- Partnering with Manufacturing to troubleshoot and drive resolution of process issues and proactively driving projects to improve manufacturing process
- Partnering with Operational Excellence to drive business process improvements through Kaizens, Kanban, 5S and VSM in their area of responsibility.
- Ensuring that internal customers and suppliers are aligned with the solutions and services of the department.
**_Basic Qualifications:
- **
- Bachelor’s degree in Engineering, Science and 0 to 2 years relevant work experience or 5 years of relevant work experience
- Experience with at least one computerized system (Werum PAS-X, DeltaV, PI, etc.)
- Direct experience with regulated environments (i.e. cGMP, OSHA, EPA).
- Demonstrated knowledge of validation requirements for control systems in CGMP and/or ASTM environments.
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