• Execute comprehensive maintenance and cleaning of automation systems and the Seidenader 40 automated vial inspection machine, including complex gear assembly, disassembly, and change parts. Utilize the HMI control panel and ABB-collaborated dual-arm robot for meticulous vial inspections, ensuring top-notch operational precision and efficiency.• Drive excellence in compliance with Quality Management Systems (QMS), Environmental Management Systems (EMS), and FDA regulations. Foster… Show more • Execute comprehensive maintenance and cleaning of automation systems and the Seidenader 40 automated vial inspection machine, including complex gear assembly, disassembly, and change parts. Utilize the HMI control panel and ABB-collaborated dual-arm robot for meticulous vial inspections, ensuring top-notch operational precision and efficiency.• Drive excellence in compliance with Quality Management Systems (QMS), Environmental Management Systems (EMS), and FDA regulations. Foster a safetycentric culture through rigorous safety inspections and incident reporting. Demonstrate expertise in Standard Operating Procedures (SOP), Current Good Manufacturing Practices (cGMP), Learning Management Systems (LMS), PAS-X for process documentation and training, and Electronic Batch Records (EBR) for accurate and efficient batch processing.• Streamline inventory and resource management by overseeing the preparation of media and buffers, dispensing raw materials, and maintaining meticulous transaction records, ensuring an impeccably organized and efficient workspace.• Enhance manufacturing operations by executing precise lab procedures, operating cutting-edge equipment, and adeptly resolving routine and complex issues. Contribute significantly to team success and operational excellence through proactive problem-solving and a commitment to continuous improvement. Show less

• Completed in-depth coursework on validation processes specific to the medical device and pharmaceutical industries, with a strong emphasis on understanding and applying Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) methodologies to ensure equipment and systems meet regulatory and operational standards.• Developed a comprehensive understanding of regulatory frameworks and compliance requirements, particularly CFR 21, and their… Show more • Completed in-depth coursework on validation processes specific to the medical device and pharmaceutical industries, with a strong emphasis on understanding and applying Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) methodologies to ensure equipment and systems meet regulatory and operational standards.• Developed a comprehensive understanding of regulatory frameworks and compliance requirements, particularly CFR 21, and their critical role in the validation and quality assurance of medical devices and pharmaceutical products, ensuring adherence to industry standards.• Gained practical knowledge in conducting Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) as essential components of the validation process, ensuring that equipment and systems are fully operational and meet specified performance criteria before and after installation Show less

• Conduct a Gage RR process used to evaluate a gauging instrument's accuracy by ensuring its measurements are repeatable and reproducible.• Created a Standard operation procedure for 3 stations within the manufacturing facility. • Assisted in the design and optimization of aluminum extrusion processes, resulting in improved efficiency and reduced waste.• Conducted statistical quality control analyses to identify areas for improvement and minimize defects in extruded… Show more • Conduct a Gage RR process used to evaluate a gauging instrument's accuracy by ensuring its measurements are repeatable and reproducible.• Created a Standard operation procedure for 3 stations within the manufacturing facility. • Assisted in the design and optimization of aluminum extrusion processes, resulting in improved efficiency and reduced waste.• Conducted statistical quality control analyses to identify areas for improvement and minimize defects in extruded products.• Collaborated with cross-functional teams to implement process modifications and ensure compliance with quality standards.• Contributed to the development of technical reports and documentation. Show less

• Design and implementation of a frame structure upgrade project in a beverage manufacturing company, transitioning from pneumatic systems to servo electrical motors.• Conducted a comprehensive assessment of existing pneumatic systems, identifying inefficiencies and opportunities for improvement.• Collaborated with cross-functional teams, including engineers and production staff, to understand system requirements and constraints.• Developed detailed design plans and specifications… Show more • Design and implementation of a frame structure upgrade project in a beverage manufacturing company, transitioning from pneumatic systems to servo electrical motors.• Conducted a comprehensive assessment of existing pneumatic systems, identifying inefficiencies and opportunities for improvement.• Collaborated with cross-functional teams, including engineers and production staff, to understand system requirements and constraints.• Developed detailed design plans and specifications for the new frame structure, considering load-bearing capacity, safety regulations, and integration with servo electrical motors.• Utilized CAD software to create 3D models and engineering drawings, ensuring precise alignment and compatibility with the new electrical system.• Worked closely with suppliers and vendors to source appropriate servo motors and related components, ensuring compatibility and performance. Show less

• Understanding of basic statistical concepts such as mean, median, mode, standard deviation, variance, probability distributions, hypothesis testing, etc. This foundation is crucial for understanding more advanced statistical techniques.• Learn about the principles of Statistical Process Control (SPC) and its objectives.Understand control charts: Their types (e.g., X-bar and R charts, p-charts, np-charts, c-charts), construction, interpretation, and application.Study control chart… Show more • Understanding of basic statistical concepts such as mean, median, mode, standard deviation, variance, probability distributions, hypothesis testing, etc. This foundation is crucial for understanding more advanced statistical techniques.• Learn about the principles of Statistical Process Control (SPC) and its objectives.Understand control charts: Their types (e.g., X-bar and R charts, p-charts, np-charts, c-charts), construction, interpretation, and application.Study control chart patterns and their significance in detecting process variations.• Understand process capability indices such as Cp, Cpk, Pp, and Ppk.Learn how to assess process capability and its significance in quality control and improvement efforts.• Understand the principles of Six Sigma methodology.Learn about DMAIC (Define, Measure, Analyze, Improve, Control) framework and its application in quality improvement projects.Study statistical tools commonly used in Six Sigma projects, such as regression analysis, ANOVA, etc. Show less