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Miles
Km80.5

Senior Process Development Engineer, Corneal Implant

FibroGen, Inc.

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Location: San Francisco, CA Posted Date: 4/11/2013 Position Type: Full time Job Code: 13BSP102 Required Education: Bachelors Degree Areas of Expertise Desired: Process Development

Description

1.The successful candidate will be  responsible for process scale-up, process equipment identification, the design of process fixtures and tooling, and conducting experiments to establish process parameters and process capability for a manufacturing process for an implantable biodegradable medical device.  The candidate is expected to play a major role in designing and developing a full-scale commercial production process.
2.Participate in process equipment IOQ, process performance evaluation, and write validation reports
3.Responsible for tech transfer to commercial production site(s)
4.Involved in clinical production activities such as preparing SOPs, batch records, and hands-on GMP production
5.Perform product testing, product performance verification and validation activities. Take responsibility for designing and executing experiments.   Author protocol and test reports.
6.Assist in Design Control activities involved with medical implant.

Requirements

The ideal candidate will be a biomechanical, biomedical, or medical engineer with 10 plus years of experiences in medical device industry.  Candidates with strong process engineering backgrounds in contact lens or intraocular lens (IOL) industry are highly desirable.  Candidates shall have a strong background in mechanical engineering, CAD, and SolidWorks.  Backgrounds in electric engineering, automation, robotics, and protein biochemistry a plus.  The candidate shall be familiar with cGMP and working in a regulatory environment.  The ideal candidate shall have a minimum education level of BS degree.  MS, PhD preferred.  Candidates with a BS degree yet strong industrial experiences will still be considered.  
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