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Validation & Engineering Group, Inc.
(V&EG) is a leading services supplier providing solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in areas such as Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to working under the highest ethical standards for the following position: Sr Manufacturing Engineer Qualifications: BS in Engineering; a master’s degree is a plus. Minimum 7 years of experience in a related engineering role, preferably in the medical device industry. CIAPR PE license is a plus. Ability to analyze information and evaluate results to determine the best solutions and solve problems. Knowledge in injection molding and other plastic processes. Knowledge of FDA, GMP, and ISO guidelines. Experience with equipment or process validation (IQ, OQ, PQ, Software Qualification, User Requirements, FAT). Strong knowledge of statistical techniques (DOE, Process Capability, Hypothesis Testing, SPC). Proficiency in computer software (Microsoft Word, Excel, PowerPoint) and scientific software (Minitab, AutoCAD, SolidWorks). Effective communication and presentation skills. Fully bilingual in English and Spanish. Responsibilities: Support manufacturing activities daily to meet goals. Troubleshoot product problems related to design, materials, or processes. Investigate operational issues like material variances or bottlenecks. Identify opportunities for process or product improvements and cost reductions. Apply continuous improvement methods, such as lean manufacturing. Prepare reports on manufacturing performance. Evaluate products against specifications and quality standards. Provide technical support related to manufacturing. Implement new manufacturing methods or processes. Review product designs for manufacturability. Identify root causes of failures and recommend design or process changes. Supervise technicians, analysts, and other staff. Analyze financial impacts of manufacturing processes. Stay updated with industry developments through literature, training, and professional organizations. Recommend process or design improvements. Manage spare parts inventory and evaluate obsolete components. Report equipment downtime and scrap metrics. Manage projects involving new equipment, process improvements, and cost reductions. Author, execute, and approve equipment/process qualifications and change requests. Investigate equipment and process issues to identify root causes and implement controls. Lead and mentor a team of hourly staff, including task assignment and performance evaluation. Conduct training, coaching, and performance reviews. Ensure smooth operations and high standards of quality and efficiency. Foster a positive work environment through effective communication and teamwork. Ensure compliance with all procedures and regulatory requirements. Perform other duties as assigned.
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(V&EG) is a leading services supplier providing solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in areas such as Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to working under the highest ethical standards for the following position: Sr Manufacturing Engineer Qualifications: BS in Engineering; a master’s degree is a plus. Minimum 7 years of experience in a related engineering role, preferably in the medical device industry. CIAPR PE license is a plus. Ability to analyze information and evaluate results to determine the best solutions and solve problems. Knowledge in injection molding and other plastic processes. Knowledge of FDA, GMP, and ISO guidelines. Experience with equipment or process validation (IQ, OQ, PQ, Software Qualification, User Requirements, FAT). Strong knowledge of statistical techniques (DOE, Process Capability, Hypothesis Testing, SPC). Proficiency in computer software (Microsoft Word, Excel, PowerPoint) and scientific software (Minitab, AutoCAD, SolidWorks). Effective communication and presentation skills. Fully bilingual in English and Spanish. Responsibilities: Support manufacturing activities daily to meet goals. Troubleshoot product problems related to design, materials, or processes. Investigate operational issues like material variances or bottlenecks. Identify opportunities for process or product improvements and cost reductions. Apply continuous improvement methods, such as lean manufacturing. Prepare reports on manufacturing performance. Evaluate products against specifications and quality standards. Provide technical support related to manufacturing. Implement new manufacturing methods or processes. Review product designs for manufacturability. Identify root causes of failures and recommend design or process changes. Supervise technicians, analysts, and other staff. Analyze financial impacts of manufacturing processes. Stay updated with industry developments through literature, training, and professional organizations. Recommend process or design improvements. Manage spare parts inventory and evaluate obsolete components. Report equipment downtime and scrap metrics. Manage projects involving new equipment, process improvements, and cost reductions. Author, execute, and approve equipment/process qualifications and change requests. Investigate equipment and process issues to identify root causes and implement controls. Lead and mentor a team of hourly staff, including task assignment and performance evaluation. Conduct training, coaching, and performance reviews. Ensure smooth operations and high standards of quality and efficiency. Foster a positive work environment through effective communication and teamwork. Ensure compliance with all procedures and regulatory requirements. Perform other duties as assigned.
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