Process Development Scientist 34630
4 days ago
Inteldot has over 14 years of experience in the life sciences industry, with allocations across Puerto Rico, the United States, Europe, and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.
Job Description:
To conceive, design, implement and execute specific scientific experiments, which contribute to the successful completion of goals and/or projects under general guidance of supervisor. Administrative shift
Requirements:
- Provide direct support to the requirement, design, and characterization of inspection/packaging process, process optimization strategies and/or troubleshooting of operational issues in the operations.
- Apply advanced and diverse engineering principles to the design and implementation of system, equipment or process modifications, experiments, process and/or capital projects.
- Develop, organize, analyze and present interpretation of results for operational issues or engineering projects.
- Provide advanced technical support to the automatic packaging equipment and processes:
- Strong Knowledge on Vision system technologies
- Inspection/packaging Concepts Knowledge
- Strong Knowledge with local process flow, layouts and general packaging SOP's to be able to define details of serialization solution.
- Support troubleshooting, investigations, root cause analysis related to the packaging area and inspection process.
- Identify and implement initiatives in the inspection/packaging processes to reduce manufacturing operational costs while maintaining product quality
- Development and Execution of Processes Characterization:
- Establish Testing Strategies
- Design / Development of Characterization Protocols
- Technical Reports Development
- Validations, and technical reports- To support SATs executions, document generation and challenge validations strategies.
- Risk assessments and QRAES knowledge, to support risk assessments activities.
- Project execution activities coordination (Material requests, Trainings, Production Windows, Work Orders generation).
General skills:
- Technical Documentation abilities verbal and written
- Documentation software (MS word, Excel, Power point, PDF, Visio, MS project)
- Project management basic concepts (timeline follow up, schedule reviews, predecessor).
- Flexibility in working time based on project needs, including 1st, 2nd and 3rd shifts and extended hours up to 12 hrs.
General Functions:
- Conceives and designs, executes or evaluates, and interprets experimental strategies.
- Provides input to new processes to generate robust and reliable data.
- Ensures that studies are conducted in compliance with the respective protocol and applicable guidelines and regulations.
- Designs, monitors or conducts experimental strategies with general guidance from supervisor.
- Provides data analysis and interpretation and assesses impact of the data on the project.
- Monitors field of expertise, including literature and technology development, and communicates relevant observations.
- Develops and implements new and novel protocols to address specific issues.
- Assists others in experimental design and/or interpretation/diagnosis of data and implementing innovative remedies.
- Independently authors scientific reports, summary documents, complex regulatory documents, invention disclosure submissions and/or patents.
Education:
- Master's degree and 2 years of Scientific experience or bachelor's degree and 4 years of Scientific experience.
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