Sr Sterilization Validations Engineer

hace 2 semanas

Tijuana, México Centerpiece S. de R.L de C. V. A tiempo completo

The Sr Sterilization Validations engineer will:- The Sr Sterilization Validations engineer eventually will work with a significant degree of independence and self-direction to ensure the developing, implementing, and executing validation related programs in compliance withCENTERPIECE’s QMS and compliant to 21 CFR Section 820, EN ISO 13485, ISO 11135, Environmental Standards, and other as necessary operating requirements.- The Sr Sterilization Validations engineer will work closely with the operations and quality teams to ensure the adherence to validations projects (budgetary, timeline, etc).- Generate validation IQ/OQ/PQ protocols, risk assessments, reports, and technical files.- This position will routinely interact with the production operations team.- Review risk assessments, commissioning protocols.- Proven technical experience with demonstrated success in working in a team environment to successfully achieve corporate goals related to new facility and equipment qualification and sterilization validation.- Must be a strategic, innovative driver of technical solutions, quality implementation, risk management and change with strong technical skills- Specific skill set: quality minded, critical thinking, technical writing, problem solving, experience in investigative techniques, highly detail oriented, and highly organized- Other duties as assignedRequired Knowledge, Skills, and Experience:- Commitment to product quality, the Centerpiece quality system, and all applicable regulations (Federal, Local,- and State).- Bachelor’s degree in engineering, or related scientific discipline (Electrical, or Chemical Engineering degree preferred) and a minimum of 5 years of progressively responsible experience in a regulated industry such as medical device or pharmaceutical.- Thorough and detailed experience with FDA Quality System Regulations (21 CFR 820), ISO 13485 and GHTF process validation guide.- Extensive experience in equipment validation and commissioning is mandatory.- Experience working in a process environment with in-depth, hands-on involvement.- Ability to successfully manage multiple projects simultaneously.- Proven technical experience with demonstrated success in working in a team environment to successfully achieve corporate goals related to new facility and equipment qualification and sterilization validation.- Experience with the following critical utility/mechanical systems: HVAC and controlled environments.Tipo de puesto: Tiempo completoSueldo: $1,600.00 - $2,500.00 al díaBeneficios:- Estacionamiento de la empresa- Horarios flexibles- Opción a contrato indefinido- Seguro de gastos médicos mayores- Vales de despensaTipo de jornada:- Lunes a viernes- Turno de 10 horas- Turno matutinoPuede trasladarse/mudarse:- 22245, Tijuana, B.C.: Trasladarse al trabajo sin problemas o planear mudarse antes de comenzar a trabajar (Obligatorio)Escolaridad:- Licenciatura terminada (Deseable)Experiência:- ISO13485: 2 años (Obligatorio)- Industria medica: 2 años (Obligatorio)- Validaciones de Esterilizacion: 2 años (Obligatorio)Idioma:- Inglés (Obligatorio)Lugar de trabajo: Empleo presencialFecha de inicio prevista: 05/11/2024

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    hace 2 semanas

    Tijuana, México Centerpiece S. De R.L De C. V. A tiempo completo

    The Sr Sterilization Validations engineer will:- The Sr Sterilization Validations engineer eventually will work with a significant degree of independence and self-direction to ensure the developing, implementing, and executing validation related programs in compliance withCENTERPIECE's QMS and compliant to 21 CFR Section 820, EN ISO *****, ISO *****,...

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