Sr. Quality Computer Validation Specialist

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. Active cellular immunotherapy holds promise because it may provide patients with a meaningful clinical benefit, such as survival, combined with low toxicity. We’re headquartered in Seattle and have our first manufacturing site in Morris Plains, NJ.  This state-of-the art facility has the capacity to support clinical processes and future anticipated commercial needs for sipuleucel-T.

Dendreon is traded on the Nasdaq Global Market under the symbol DNDN. For more information about the Company and its programs, visit www.Dendreon.com.

 

We are seeking a Senior Quality Computer Validation Specialist responsible for GXP validation and change control activities.  This is a small team of grounded and diligent people who are committed to ensuring our systems are everything they should be to support our company mission.  In this role, you’ll wear multiple hats and utilize a variety of skills from technical, investigative, facilitative, and relationship building.  If you want to expand your technical and your interpersonal skills, this could be the role for you.  Whereas, if you prefer a less-people oriented role, there are probably other positions that would suit you better.  

 

Description: Ensure computer systems comply with all GXP and 21/CFR Part 11 requirements.Represent Quality on inter-departmental project teams that are developing and/or implementing systems to ensure compliance with regulatory requirements and anticipate the introduction of new requirements by monitoring industry guidance and trends.Administer the Change Control programs.Review and approve validation plans, user/functional requirements, design specifications, test protocols (IQ, OQ and PQ) and final reports for Computerized Systems within the guidelines of GMP and internal policies. Ensure compliance with validation approach and requirements.Review and/or perform risk assessments. Perform audits of computerized systems back up, restore, disaster recovery and security. Support the Dendreon QA/Compliance department in any regulatory inspections or audits.

 

Requirements: Bachelor’s degree in a technical or scientific discipline or equivalent. Typically 5 years of related experience in a regulated environment. Understanding of computer systems life cycle validation principlesSome travel may be required.  

 



We offer a competitive compensation and benefits package, including bonus, matching 401(k) & stock options.  Please visit http://www2.recruitingcenter.net/clients/Dendreon/publicjobs/ to submit your resume.