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Engineering Process Consultant
2 months ago
Key Responsibilities:
- Deliver hands-on assistance for process optimization, troubleshooting, and enhancement projects.
- Develop and validate Work Instructions, Production Records, and other essential documentation for operational processes.
- Provide recommendations for process enhancements and ensure that controls are validated through method or system validation.
- Lead or support investigations for identified compliance issues, including Corrective and Preventative Actions and Non-Conformance Reports.
- Bachelor's degree in a relevant discipline.
- 5-8 years of experience in the Medical Device or In Vitro Diagnostics sectors.
- Preferred experience in cartridge production, microfluidic technologies, or DNA sequencing.
- Prior experience in process mapping, documentation development, and testing within production settings is highly advantageous.
- Strong analytical skills with proficiency in statistical analysis, Design of Experiments (DOE), and tools such as Minitab for data evaluation and interpretation.
- Experience in raw material assessment, including visual inspections, chemical evaluations, and surface analysis.
- Expertise in process validation, equipment qualification, and adherence to relevant industry standards and regulations.
