Our client, located in Berkeley Heights, New Jersey, is seeking a Computer Systems Validation Manager to perform the following duties: * Maintain computer systems in compliance with policies, guidelines, and procedures * Supervise electronic records management * Assist key customer groups in the operation of application software * Conduct training of staff regarding computer validation, electronic records management, and other Quality Assurance topics * Prepare and execute computer system validation documents * Perform compliance assessments of computerized systems * Supervise the daily activities of junior staff and responsible for validation project management Qualifications: * BS or BS/MS degree in Computer Science, Chemistry, Life Sciences or Engineering * 7-10 years experience in Information Technology * Experience with GxP regulations, GAMP, and good documentation practices * Knowledge of analytical laboratory data systems or manufacturing automation * Knowledge of clinical systems * Knowledge of computer network and system security principles * Experience with 21 CFR 11 * Experience creating and executing computer systems validation documents * Ability to interact effectively with laboratory, QA, and IT groups * 5 years experience in FDA-regulated industries and 7-10 years computer automation/validation experience Preferred Skills/Knowledge: * 2 years experience creating SQL + queries under Oracle 8i or newer * 2 years experience creating reports using Crystal Reports 10 or newer * 2 years experience performing manual/automated testing using tools such as Mercury Quality Center