Senior System Validation Assoc.

Celgene is a multinational biopharmaceutical company committed to improving the lives of patients worldwide.  Our mission as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.  Celgene is currently seeking a Senior System Validation Associate. 

 

Responsibilities will include, but are not limited to the following:Management of computer validation projects for COTS and internally developed systems supporting cGxP-regulated operations. Development of software development life cycle (SDLC) validation documentation.Development of policies, guidelines, and procedures governing validation and maintenance of cGxP compliant computer systems.Conduct training of Celgene staff regarding computer validation, electronic records management, and other Quality Assurance topics.Provide collaborative support and solutions to a variety of complex problems to Celgene computer system owners and Celgene IT stakeholders regarding computer validation requirements.Project Lead for IT System Validation Group on multi-functional project teams as a technical expert regarding validation of corporate/global systems.Coordinate the daily activities of, and provide mentoring to, validation testing staff/consultants.Develop and introduce new validation methodologies, tools, and technologies.Other responsibilities as assigned by their supervisor.

 

Skills/Knowledge Required:MS degree (or BS with 2 additional years of experience) in Computer Science, Quality Assurance, or Engineering.10+ years experience in Computer Validation.Expertise in analytical laboratory data systems, manufacturing automation, or clinical trial data management principles.Knowledge of computer network and system security principles.Familiarity with 21 CFR 11, GxP, SOX, and HIPAA requirements.Ability to interact effectively within large multi-disciplinary teams.Significant project management experience.