Sr Sterilization Validations Engineer

hace 2 días

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 with

CENTERPIECE’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 assigned

Required 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 completo

Sueldo: $1,600.00 - $2,500.00 al día

Beneficios:

- Estacionamiento de la empresa
- Horarios flexibles
- Opción a contrato indefinido
- Seguro de gastos médicos mayores
- Vales de despensa

Tipo de jornada:

- Lunes a viernes
- Turno de 10 horas
- Turno matutino

Puede 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 presencial

Fecha de inicio prevista: 05/11/2024

  • Sr Sterilization Validations Engineer

    hace 4 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,...

  • Sr Sterilization Validations Engineer

    hace 4 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 *****,...

  • Sr. Sterilization Engineer

    hace 7 días

    Tijuana, México Mammotome A tiempo completo

    Sterilization Engineers are responsible for providing technical expertise and business leadership to engineering, operations, regulatory teams in sterilization and microbiological areas. The basic function of the Sterilization Engineer at the manufacturing site is to plan, coordinate and direct the sterilizatio program to ensure continuous accomplishment of...

  • Sr. Sterilization Engineer

    hace 7 días

    Tijuana, México Mammotome A tiempo completo

    Sterilization Engineers are responsible for providing technical expertise and business leadership to engineering, operations, regulatory teams in sterilization and microbiological areas. The basic function of the Sterilization Engineer at the manufacturing site is to plan, coordinate and direct the sterilizatio program to ensure continuous accomplishment of...

  • Sr. Sterilization Engineer

    hace 7 días

    Tijuana, México Mammotome A tiempo completo

    Sterilization Engineers are responsible for providing technical expertise and business leadership to engineering, operations, regulatory teams in sterilization and microbiological areas. The basic function of the Sterilization Engineer at the manufacturing site is to plan, coordinate and direct the sterilizatio program to ensure continuous accomplishment of...

  • Environmental and Sterilization Quality Engineer

    hace 3 semanas

    Tijuana, México Carlisle Medical Technologies A tiempo completo

    Descripción y detalle de las actividadesResponsibilities: - Develop and Coordinate Environmental and Sterilization Plans to comply with applicable regulations. - Provide support on Environmental and Sterilization Validations, including but not limited to the development of Protocols and Reports. - File, update, and maintain Environmental and Sterilization...

  • Environmental and Sterilization Quality Engineer

    hace 4 semanas

    Tijuana, México Carlisle Interconnect Technologies A tiempo completo

    Responsibilities:- Develop and Coordinate Environmental and Sterilization Plans to comply with applicable regulations.- Provide support on Environmental and Sterilization Validations, including but not limited to the development of Protocols and Reports.- File, update, and maintain Environmental and Sterilization records in accordance with applicable...

  • Sterilization Quality Engineer

    hace 3 semanas

    Tijuana, México Flex A tiempo completo

    Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world.We believe in the power of diversity and inclusion and cultivate a workplace culture of belonging that views uniqueness as a competitive edge and builds a community that enables our people to push the...

  • Sterilization Process Leader

    hace 7 días

    Tijuana, México Mammotome A tiempo completo

    A leading global manufacturer located in Tijuana, Baja California is seeking a Sterilization Engineer. In this role, you will ensure compliance with sterilization standards, lead testing and audits, and manage cross-functional collaborations. You will contribute to the improvement of sterilization processes and training activities to enhance product...

  • Sterilization Process Leader

    hace 7 días

    Tijuana, México Mammotome A tiempo completo

    A leading global manufacturer located in Tijuana, Baja California is seeking a Sterilization Engineer. In this role, you will ensure compliance with sterilization standards, lead testing and audits, and manage cross-functional collaborations. You will contribute to the improvement of sterilization processes and training activities to enhance product...