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Software Validation Engineer

Johns Creek, GA, US


JOB TYPE: Permanent, FullTime

Title Software Validation Engineer Location Johns Creek, GA (almost 1 hour away from Atlanta, GA) Type Contract for 6 months JOB DESCRIPTION The Validation Engineer will lead andor assist validation efforts for client's RD. The position will be responsible for preparing the validation strategy and guidance via the review, writing, and executing validation activities. The Validation Engineer will provide the coordination and execution of qualification and validation activities including (but not limited to) writing protocols, performing qualifications, review of documents that support RD VC facilities. In addition Validation Engineer will have an understanding of how the various pieces of RD equipment operate, and understand the principle of Validation and Engineering to ensure compliance with 21 CFR requirements and RD VC policies and procedures. The position will require hands-on experience in all areas of validation including equipment qualification, performance qualification, process validation, cleaning validation, computer system validation, and facility utilities qualification. Execution of validation plans and validation protocols for VC RD projects that impact facility, processes, equipment, cleaning, and software systems. Prepare and or revise validation protocolsprocedures as required. Review and execute qualification and summary reports, write and revise as needed. Update the site master validation plan to reflect current validation status. Participate in review of RD operational SOPs that apply to validated equipment, facilities and processes. Assist in troubleshooting, complex or usual problems arising from equipmentsystem failures. Ensure continuous validation maintenance for equipment, facility and process through the change control program. Analyze validation data, prepare reports, and make recommendations for changes and orimprovements. Coordinate generation and completion of any deviations, equipment and document change control resulting from a qualification and or validation activity. Assist in defining and implementing acceptance criteria, specifications, and standards for each qualification activity. BS degree in Mechanical, Electrical Engineering or Chemistry (Master's degree preferred) Years of Experience 5 to 8 years preferably Working knowledge of Windchill EEO Employer Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or 844-463-6178.