Sr Sterilization Validations Engineer

Detalles de la oferta

The Sr Sterilization Validations Engineer will:Work with a significant degree of independence and self-direction to develop, implement, and execute validation-related programs in compliance with CENTERPIECE's QMS and applicable regulations.Collaborate closely with the operations and quality teams to ensure adherence to validation projects (budgetary, timeline, etc).Generate validation IQ/OQ/PQ protocols, risk assessments, reports, and technical files.Interact routinely with the production operations team.Review risk assessments and commissioning protocols.Demonstrate proven technical experience in a team environment to achieve corporate goals related to new facility and equipment qualification and sterilization validation.Be a strategic, innovative driver of technical solutions, quality implementation, risk management, and change with strong technical skills.Exhibit specific skills: quality-minded, critical thinking, technical writing, problem-solving, experience in investigative techniques, highly detail-oriented, and highly organized.Perform 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 preferred) with a minimum of 5 years of progressively responsible experience in a regulated industry such as medical devices or pharmaceuticals.Thorough 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 manage multiple projects simultaneously.Experience with critical utility/mechanical systems: HVAC and controlled environments.Job Type: Full-timeSalary: $1,600.00 - $2,500.00 per dayBenefits:Company parkingFlexible hoursOption for indefinite contractMajor medical expense insuranceMeal vouchersWork Schedule:Monday to Friday10-hour shiftMorning shiftRelocation:22245, Tijuana, B.C.: Must commute to work without issues or plan to relocate before starting work (Mandatory)Education:Completed Bachelor's degree (Preferred)Experience:ISO13485: 2 years (Mandatory)Medical industry: 2 years (Mandatory)Sterilization validations: 2 years (Mandatory)Language:English (Mandatory)Work Location: On-siteExpected Start Date: 05/11/2024#J-18808-Ljbffr


Fuente: Jobtome_Ppc

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