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Company Name
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Sanofi Pasteur
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Industry
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Medicine
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Job Functional Area
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Engineering
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Job Title
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Manager Associate process Engineer
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Job position
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1
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Job Type
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Permanent/ Day shift
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Job Location
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United
States-Pennsylvania-Swiftwater
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Minimum Education
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B.S in Engineering and Science
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Minimum Experience
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1-3 years of visual inspection experience
Equipment qualification / process validation
experience
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Job Description
- This position is for Manufacturing Technology of Industrial Operations. The mission of Manufacturing Technology is as follows
- Deliver robust and efficient process & testing with associated know how to transfer to QC and Manufacturing.
- Support manufacturing and QC on a daily basis toward industrial excellence to guarantee the accuracy, conformity and competitiveness of the processes and techniques utilized for the production of the vaccines and biologic manufactured at the pasteur industrial sites.
- Participate in the execution of technical studies to industrialize inspection processes for Phase 3 and licensed production.
- Participate in the execution of technical studies to industrialize inspection processes for Phase 3 and licensed production.
- Assure the commercialization of robust, compliant, and efficient inspection processes for vaccines and bio pharmaceuticals.
- Participate in programs that use structured methodologies, such as Quality by Design, Design Space, & Process Control Strategies in the course of industrial process design, validation and control.
- Have a high level of expertise and understanding of visual inspection technologies, automated visual inspection equipment qualification, optimization of automated visual inspection configurations, preparation and qualification of product defect sets, and primary packaging components.
- Draft and execute protocols and prepare summary reports supporting Performance Qualification of automated inspection machines. Conduct inspection capability studies.
- Contribute to the definition of critical process attributes for process validation. Communicate and interpret documented study results within the platform or project.
- Conduct process monitoring studies and use data from the inspection processes to present recommendations on upstream optimization.
- Author, train, and/or implement instruction on new/improved inspection processes to appropriate audience.
- Comply with cGMP and other internal and external quality and regulatory guidance. Comply with health and safety guidelines.
Desired Skills
- Demonstrated technical writing and problem solving skills
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