Sterilization Validation Engineer
hace 3 semanas
The Sr. Sterilization Validations Engineer will be responsible for developing, implementing, and executing validation-related programs in compliance with Centerpiece's QMS and applicable regulations. They will work closely with operations and quality teams to ensure validation projects adhere to budget, timeline, and other requirements.
Key Responsibilities:
- Generate validation IQ/OQ/PQ protocols, risk assessments, reports, and technical files.
- Collaborate with production operations teams and review risk assessments and commissioning protocols.
- Demonstrate technical expertise in a team environment to achieve corporate goals related to new facility and equipment qualification and sterilization validation.
- Develop technical solutions, quality implementation, risk management, and change with strong technical skills.
- Perform other duties as assigned.
Requirements:
- Commitment to product quality, Centerpiece's quality system, and all applicable regulations.
- Bachelor's degree in engineering or related scientific discipline with a minimum of 5 years of experience in a regulated industry.
- 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.
- Ability to manage multiple projects simultaneously.
- Experience with critical utility/mechanical systems: HVAC and controlled environments.
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