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 *, ISO *, 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 * 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: $2,** - $2,** al día
Beneficios:
- Estacionamiento de la empresa
- Horarios flexibles
- Opción a contrato indefinido
- Confiable de gastos médicos mayores
- Vales de despensa
Puede trasladarse/mudarse:
- Tijuana, B.C.: Trasladarse al trabajo sin problemas o planear mudarse antes de comenzar a trabajar (Obligatorio)
Escolaridad:
- Licenciatura terminada (Deseable)
Experiência:
- ISO*: 2 años (Obligatorio)
- Industria medica: 2 años (Obligatorio)
- Validaciones de Esterilizacion: 2 años (Obligatorio)
Idioma:
- Inglés (Obligatorio)
Lugar de trabajo: Empleo presencial

📌 Sr Sterilization Validations Engineer (Tijuana)
🏢 Centerpiece S. de R. L de
📍 Tijuana