Process Engineer I

Zosano Pharma, Inc.

Location: Fremont, California-Oakland/East Bay 94555
Posted on: 9/30/2009 5:35:45 PM
Postion type: Full time
Job Code: 2009-23/24
Required Education: Bachelor's Degree
Salary:

DESCRIPTION
Process Engineer I

Zosano Pharma, Inc., is a private specialty pharmaceutical company creating better products utilizing innovative drug delivery technology. Zosano Pharma is built upon the resourcefulness, talent, insight, and drive of our employees. We all share a common commitment to work toward achieving the Company’s goals. This commitment provides the basis for a productive and collaborative effort, promotes personal and professional growth, and helps to ensure our continued success.

Responsible for the support of the manufacturing process of a novel intradermal drug delivery device. The candidate will monitor performance of the manufacturing processes using SPC methods, correct equipment problems, analyze non-conforming products, remediate low yields, and correct product quality issues.

The ideal candidate will have at least 0 to 2 years of relevant experience in the medical device and/or pharmaceutical industry and a BS or equivalent in a related discipline. Outstanding communication skills are essential.

DUTIES AND RESPONSIBILITIES (Other duties may be assigned):
• Provide technical oversight of the manufacturing processes during production.
• Monitor the process critical attributes using SPC methods and issue monthly summary reports.
• Create and upgrade operational procedures used by manufacturing personnel to perform production.
• Identify, investigate, and resolve production yield issues. Review production yield information and determine primary factors affecting product quality and yield.
• Initiate, investigate, and resolve process related non-conformances.
• Support the execution of process development investigations (including building of experimental supplies, execution of experimental protocols, and analysis of data).

REQUIREMENTS:
• Relevant knowledge of GXP compliance regulations and industry practices. Specifically, the requirements outlined in 21 CFR, Parts 210 & 211, and their practical application. The ability to evaluate and implement processes, procedures and practices for conformance to these requirements.
• Ability to critically evaluate, troubleshoot, and resolve production issues.
• The ability to prioritize and manage multiple projects concurrently under tight time constraints.
• Demonstrated commitment to proactive-planning and problem-solving.
• Aseptic manufacturing experience is highly desired.
• Must have computer skills including Microsoft Word, Excel, Power Point, Visio and Project
• Must be willing and able to work flexible hours (nights and weekends).

Zosano’s culture reflects the values of integrity, teamwork, innovation, performance, and a customer focus where high energy people join together everyday to surpass expectations. Zosano Pharma offers a competitive compensation & benefits program, along with all the excitement and energy you’d expect to find at a promising young start-up. To apply, please email your resume & cover letter to: hr@zosanopharma.com. Please reference Job Code #2009-23/24 and Process Engineer I in the subject title.

Zosano Pharma is proud to be an equal opportunity employer.
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