SR. CLEANROOM ENGINEER (MEXICALI, B.C.)
Descripción de la oferta de empleo
Primary Function of Position.
The senior cleanroom engineer is the ISI subject matter expert for Controlled Environment Room (CER) regulatory standards and compliance, operational procedures, and industry best practices.
Manage and continuously improve CER operating procedures and controls and drive implementation across the organization.
Roles & Responsibilities.
Specify and participate in new CER designs, startup, and validations Develop CER specifications and operating procedures as needed for new product, process, or regulatory requirements.
Review, manage, and approve changes or modifications to CERs, new processes, equipment, and materials.
Develop, promote, and implement CER operations training programs and initiatives Train, coach, and advise colleagues and new hires as needed for problem solving, risk management, and CER best practices Specify, review, and approve consumable operating and cleaning supplies Challenge, continuously improve, and document CER cleaning methods, frequency, and efficacy Document requirements and assist in evaluating new CER service suppliers for capability, infrastructure, and compliance.
Ensure CER service suppliers are trained to relevant ISI procedures Drive consistent practices across all sites, domestic and international Drive, manage and review environmental and product nonconformance issues Subject matter expert for cleanroom operations during quality and regulatory audits, such as FDA, MDSAP, and other governments and agencies Skills, Experience, Education, & Training.
Candidates must be willing to change residence to Mexicali (Relocation bonus available).
5 -10years relevant experience in a medical device or pharmaceutical company.
Experience in design, build, validations, and troubleshoot of CER.
Experience in HVAC systems for CER.
Bilingual English and Spanish, capable of fluent business conversations (English 80% and over) Bachelor’s degree in Engineering, Microbiology, Quality, or similar Demonstrated understanding of medical device QMS and regulatory requirements, including but not limited to FDA CFR , ISO, ISO, ISO, IEST RPs.
Demonstrated understanding of engineering change controls, process verification and validation, and production and process controls in a medical device Controlled Environmental Room Experience with developing and maintaining Standard Operating Procedures and Work Instructions Experience with the startup and validation of new facilities Participation in internal /external quality and regulatory compliance audits Puesto.
Control Ambiental
Detalles de la oferta
- INTUITIVE
- En todo México
- Sin especificar - Sin especificar
- Sin especificar
- 14/05/2024
- 12/08/2024
Required/minimum skills/qualifications: minimum 2+ years relevant experience as technical/functional consultant or engineer engineering or master’s degree in computer science/information technology (it) or equivalent relevant product certifications from microsoft excellent communication skills - verbal......
Role: sr data scientistlocation: guadalajara & mexico city (remote)type of hire: full time job description: strong proficiency with r, sql,strong in python including the tensorflow, keras, and xgboost libraries... otros datos del puestorole: sr data scientistlocation: guadalajara & mexico city (remote)type......
Importante empresa multinacional de origen suizo esta en búsqueda de tu talento como: project engineer escolaridad: ingeniero mecánico (titulado)... inglés avanzado (la entrevista es en inglés) edad: 26 a 30 años experiencia laboral de 3 a 4 años como mechanical engineer o en ingeniería de proyectos......
Comrador sr ¿te gustaría pertenecer a una comercializadora de suministros industriales con más de 30 años de experiencia en el mercado y una de las más importantes del país? ¡buscamos comprador sr! funciones: identificar y gestionar el aprovisionamiento de necesidades de compra por unidad de negocio......
Descripción del empleo estamos buscando un analista de procesos sr para unirse a nuestro equipo dentro de la industria farmacéutica... así mismo debe sugerir procesos futuros, dándole las mejores estrategias al cliente... experiencia en el uso de herramientas de colaboración, como slack, teams, etc......
¿te gustaría ser parte del equipo? nuestro/a sr web designer se encarga de diseñar los proyectos web de nuestros clientes más importantes, dando visibilidad, seguimiento de cada uno y liderar al equipo de diseño web... requisitos del puestorequisitos:- lic... la creatividad y el liderazgo son importantes......
Job title : azure machine learning – technical support engineer location : guadalajara city, mexico – initially remote job type : fulltime job description:: knowledge with azure machine learning and how it works with associated azure services... responsible for providing technical support and expertise......
Essential: graduated industrial engineer or related... maximum age 30 years old requisitos del puesto advanced ms office skills strong communication, interpersonal, customer service, and sales skills... project management and supervision... easy communication with clients... excellent technical and problem-solving......
El project buyer sr... en la compra de aceros como material directo (negociaciones de precio, ltas, cost reductions y desarrollo de proveedores)... soft skills: orientado a resultados... inglés de negocios exp... sap apqp y core tools otros datos del puestoperfil del aplicante: ing......
Funciones: prospección de clientes... sé parte de nuestro equipo, estamos solicitando personal para nuestro departamento de ventas... ofrecemos: sueldo base comisiones prestaciones de ley (afiliación al imss desde el primer día, vacaciones, aguinaldo, prima vacacional)... orientado a resultados......
