
Engineer, Manufacturing System
1 week ago
To drive automation, software and system related enhancements or key projects including site / manufacturing expansion projects.
- To ensure systems are in compliance to site Quality and HSE requirements
**Responsibilities**
- Maintain, support and administrate the MES system. Perform MES system change and related enhancements / bug fixes.
- Maintain and perform routine system / server health check.
- Drive key site initiatives/ projects from planning to project completion.
- Lead and support automation/system related projects.
- Lead the development, harmonization, implementation, execution and adherence to computer system validation procedure and methods.
- Develop/review project documentations and related SOPs.
- Perform system/software validation.
- Perform, review and approve SOP updates.
- Ensure compliance to GxP and HSE
- Liaison with site, global and regional Alcon counterparts and vendors for project planning and implementation.
- Conduct investigation for Non-conformance (NCR)
**Education**
- Degree or Diploma in Engineering or Computer Science or equivalent
**Experience**
- 5 years of experience in engineering or manufacturing industries, preferred with 2+ years in medical device or pharmaceutical manufacturing environment. Knowledge and experiences in Manufacturing Execution System (MES) and Supervisory Control Automation and Data Acquisition (SCADA).
- Sound technical problem solving skills with experience in advanced manufacturing equipment engineering.
- Hands on knowledge on automation engineering, MES/SCADA systems, Oracle/Microsoft SQL/Access database, Microsoft Visual Basic and IT (Infrastructure and Network).
- Good communication skills and able lead a team.
- Six Sigma certification preferred
- Knowledge on 21 CFR Part 11 (computerized system validation) is preferred
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