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 Companys 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).
Zosanos 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 youd 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.
