Validation Engineering

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Empresa

Tekniplex

Descripción de la Empresa

Natvar is an innovative global supplier of precision medical tubing solutions for a broad spectrum of medical device products which target hospital, physician, dental healthcare and in-home use. Our global footprint is supported by four manufacturing facilities located in the United States, Costa Rica, Asia and Europe.

Provincia

Cartago

Localidad

Parque Industrial Zeta

Tipo de Contratación

Tiempo Completo

Descripción de la Plaza

The Validation Engineer will be responsible for performing and overseeing the validation of manufacturing processes. Support the quality assurance of all activities within the process, ensuring that all systems are running according to the specifications and operations standards monitoring budget, and controlling purchase and documentation

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Lead/ support/conduct IQ, OQ, PQ validation studies of equipment and processes validations.
• Select and utilize a wide range of appropriate statistical methodologies and techniques.
• Participate on technical project teams as subject matter expert on validation regulations/procedures.
• Give advice to project teams, develop/review and approve validation protocols and final reports.
• Assist with/conduct validation studies.
• Design process characterization studies, conduct statistical analysis of results using Minitab or equivalent to identify critical parameters and improve process
• Generate and resolve protocol discrepancies or deviations.
• Continually improve the Quality System Validation program.
• Participate in project planning, scheduling, and tracking.
• Develop and implement procedures to comply with corporate and industry standards.
• Organize and archive validation documentation.
• Provide validation training to Operations employees.
• Mentor support, validation and staff engineers.
• Support the response to customer quality concerns, following six-sigma methodology to determine root cause of problems

EDUCATION and/or EXPERIENCE:
• A Bachelor’s degree in a related engineering field such as Mechanical, Industrial, or Chemical is required with 2+ years in Quality/validation or Medical Device Industry Engineering roles working with validation, qualification of equipment experience or equivalent combination of education and experience.
• Ability to independently apply analytical skills, complex scientific technical principles, and detailed knowledge in solving engineering problems.
• Knowledgeable in computer programs including Microsoft Word and Excel.
• Ability to learn how equipment functions and then design appropriate validation/qualification protocols.
• Clear understanding and application of DOE, DFMEA, and PFMEA methodologies
• Experience with Statistical Process Control methods (control charts, Cpk’s etc.)
• Knowledge of good manufacturing practices (GMP’s) encompassing plastics extrusion lines, and calculations of speeds, material composition understanding, comprehension of the basic function of fixtures and familiarity with inspecting and checking methods. Proficient in GD&T and metrology. Ability to read and interpret prints and tool designs.
• Ability to troubleshoot solve problems independently or as part of a team.
• Excellent verbal and written communication skills - Ability to internally and externally discuss and clearly define key technical and process development issues and independently develop course of action/plans.
• Knowledge of Six Sigma is required and certification is a plus.

Mínimo Nivel Académico Requerido

Universidad Completa

Mínimo Nivel de Inglés Requerido

Avanzado

Mínima Experiencia Laboral Requerida

3-4 años

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