Job Description

Job Description

Job Description

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Sr Manufacturing Engineer

Qualifications:

• BS in Engineering, 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
• Capacity to analyze information and evaluate results to choose the best solution and solve problems. o Knowledge in injection molding and other plastic processes, preferred.
• Knowledge of FDA, GMP, and ISO guidelines is required.
• Knowledge in equipment or process validation (Installation Qualification, Operational Qualification, Performance Qualification, Software Qualification, User Requirements Specification, Factory Acceptance Test) required.
• Strong statistical techniques knowledge (DOE, Process Capability, Hypothesis Testing, SPC) is required.
• Strong computer software knowledge (Microsoft Word, Excel, Power Point). o Analytical or scientific software — Minitab, Autodesk AutoCAD, SolidWorks.
• Effective communication and presentation skills. o Fully Bilingual (English and Spanish).

Responsibilities:

• Daily support to manufacturing activities to meet established goals.
• Troubleshoot new or existing product problems involving designs, materials, or processes.
• Investigate or resolve operational problems, such as material use variances or bottlenecks.
• Identify opportunities or implement changes to improve manufacturing processes or products or to reduce costs, using knowledge of fabrication processes, tooling and production equipment, assembly methods, quality control standards, or product design, materials and parts. • Apply continuous improvement methods, such as lean manufacturing, to enhance manufacturing quality, reliability, or cost-effectiveness. • Prepare reports summarizing information or trends related to manufacturing performance. • Evaluate manufactured products according to specifications and quality standards. • Provide technical expertise or support related to manufacturing. • Incorporate new manufacturing methods or processes to improve existing operations. • Review product designs for manufacturability or completeness. • Determine root causes of failures or recommend changes in designs, tolerances, or processing methods, using statistical procedures. • Supervise technicians, technologists, analysts, administrative staff, or other engineers. • Analyze the financial impacts of sustainable manufacturing processes or sustainable product manufacturing. • Read current literature, talk with colleagues, participate in educational programs, attend meetings or workshops, or participate in professional organizations or conferences to keep abreast of developments in the manufacturing field. • Recommend technical design or process changes to improve efficiency, quality, or performance. • Responsible to provide necessary information to maintain appropriate spare parts inventory and evaluation of replacements for obsolete components. • Report equipment downtime and scrap per unit metrics
• Manage projects which include new production equipment, process improvements and cost reductions while supporting new product introductions. Work with finance to define project costs and financial analysis. • Author, execute, and approve equipment/process qualifications. Write and approve change requests. • Perform investigations of equipment and process issues to identify root cause, implement controls to eliminate causes, and assess the effectiveness of the controls.
• Provide leadership and guidance to a team of hourly associates, including assigning tasks, setting clear goals, and monitoring performance.
• Facilitate training sessions to ensure team members are equipped with necessary skills and knowledge. Develop individual team members through coaching and mentoring.
• Conduct regular performance evaluations, provide constructive feedback, and implement performance improvement plans as needed. Recognize and reward outstanding performance.
• Ensure smooth operations by coordinating workflows, resolving issues, and addressing concerns promptly.
• Maintain high standards of quality, productivity, and efficiency.
• Foster a positive work environment through effective communication.
• Encourage collaboration and teamwork to achieve organizational goals. Contribute to a positive work environment by fostering open communication, teamwork, and commitment to excellence.
• Ensure compliance with all TPR procedures and all applicable regulatory agency requirements.
• Other duties as assigned

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