Please visit http://www.dendreon.com/careers / to submit your resume.

 Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the discovery, development and commercialization of novel therapeutics that harness the immune system to fight cancer.​ The Company applies its expertise in antigen identification, engineering, and cell processing, to produce active cellular immunotherapy product candidates designed to stimulate a cell-mediated immune response.​ Dendreon is traded on the NASDAQ Global Market under the symbol DNDN.​

 Dendreon is seeking Senior Computer Systems Validation Specialists to develop and design the validation plans and testing protocols for computer-automated systems. Dendreon is a fast-paced high volume production environment with extremely high quality and regulatory standards. Efficiency and accuracy are essential to success in this job. 

General Summary: 

Performs a wide variety of activities, which may include one or more of the following:

·  Develops and designs the validation plan and testing protocols for computer-automated systems. 

·  Performs and leads test coverage analysis and execution of test protocols to ensure computer systems comply with regulatory requirements.

·  Analyzes data, prepares and reviews test results, and writes validation reports. 

·  Develops, reviews and approves internal Standard Operating Procedures.

·  Trains other department personnel in specific procedures and analytical techniques.

·  Represents department in cross-functional teams, projects and GXP-related problem resolution.

Job Requirements:

·  Bachelor’s degree in computer science or technical discipline or equivalent.

·  Typically 5 - 8 years related experience in cGMP/FDA regulated industry. 

·  Solid knowledge of desktop, server, applications and network basics.

·  Must have 2 years of ether LIMS, EDMS or ERP ( Oracle ) validation experience. 

·  Must have 5 year related to 21 CFR part 11.

Benefits:

We offer a competitive compensation and benefits package, including bonus, matching 401(k) & stock options.

Please visit http://www.dendreon.com/careers / to submit your resume.