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|Job Category :||Engineering|
|Position Name:||Validation Engineer|
|Location :||Roswell, GA 30076|
|Job Description :||KEY DUTIES AND RESPONSIBILITIES Leads and performs software, equipment, and process validations with guidance/support from Quality Engineering Management Performs Quality review of software, equipment, and process validations Operates under the supervision of Quality Management Leads or participates in corporate or quality projects for continuous improvement and to identify potential quality issues Identify opportunities for Quality within software processes, e.g., ability to identify Quality Management System (QMS) needs Maintains validation state of control in collaboration with quality Contributes to the infrastructure for new products Setting up quality controls for engineering roles and responsibilities for equipment and processes Perform statistical analysis and design experiments to support processing development, process control, and process improvement Designs models and drawings using applicable CAD programs. Also, reviews junior level engineers’ drawings for accuracy Collect, analyze data and prepare key performance reports to management Cross-functional collaboration with Operations, R&D, and IT Performs root cause analysis efforts for CAPA, Nonconforming Product, Deviations, and Investigations Supports calibration and preventative maintenance programs for production equipment, test equipment, analytical equipment, and the facility Develops and sustains Risk Management files while maintaining governing regulations, standards and internal compliance EDUCATION/CERTIFICATION Bachelor’s degree in a technical/relevant field, with at least five (5) years of Quality Assurance and related Software experience in a pharmaceutical, medical device, biologic, or tissue banking FDA regulated facility; or an appropriate combination of education, certification and work experience REQUIRED KNOWLEDGE and EXPERIENCE Knowledge and understanding of regulatory requirements, including but not limited to 21 CFR 1271, AATB, ISO 13485, cGTP, cGMP, 21 CFR 820, 21 CFR 210 & 211, and other applicable state and federal regulations Knowledge of IEC 62304 (FDA Software Validation), FDA quality systems regulation, and FDA 21 CFR part 11 Software/equipment/process/test method validation experience Ability to support the regulatory team in writing, validating, and testing requirements Experience with analytical and software validations and qualification Ability to represent Quality and Regulatory on multiple software projects Quality Analyst with a strong software background Ability to identify Quality Management System (QMS) needs Ability to support production and the production team PREFERRED KNOWLEDGE Experience in ISO 13485 ASQ Certification preferred Greenbelt (or higher) in Lean Six Sigma|