• Review production information to understand the methods and activities in manufacturing and services. This includes, but is not limited to production programs, process flows and engineering specifications.
• Design control systems to minimize and solve the problems of production and cost of the project or product.
• Create systems and production plans that guarantee that all products comply with quality standards and international regulations.
• Conduct and supervise improvement and cost reduction projects.
• Develop standards for production and design working with management.
• Analyze variations in manufacturing orders.
• Interact with internal and external suppliers.
• Experience as a validation engineer for at least 2 years.
• At least 2 years of experience in companies regulated by the FDA 21 CFR 211 or 21 CFR 820.
• Industrial Engineering, Mechanical or Chemical Engineering or related.
• Knowledge of validations in Pharmaceutical or Medical Industry (IQ, OQ and PQ).
• Knowledge of processes for ECO or DCN.
• Experience in FMEA implementation (dFMEA, pFMEA)
• Management of software such as office, Minitab, AutoCAD and design softwares.
• Experience in implementing FMEA (dFMEA, pFMEA) and DOE.
• English language at a minimum of 90%.
• Organized and self-directed.
• Sense of urgency.
• Schedule availability.
• US Valid Visa.
Div. Markwins (Parq. Ind Thomas Alva Edison) Blvd 2000
|Edad||25 - 45 años|
|Horario||Lunes a viernes|