The Sterilization Validation Engineer will be based in Austin, TX. In this role you will be responsible for coordination and implementation of in-house E-Beam Sterilization equipment and processes. This includes validation and sustaining processes to support sterilization activities.
We are looking for someone who demonstrates:
- Intense collaboration
- Passionate customer focus
- Thoughtful, fast, disciplined execution
- Tenacious commitment to continuous improvement
- Relentless drive to win
Here is a glimpse of what you'll do…
- Author, review, and execute validation protocols to support Sterilization Validation and re-validation activities for New Product Introduction and Sustaining in accordance with FDA/AAMI/ISO/EN guidelines/standards.
- Participate in the generation and/or update of the validation plan and validation status lists.
- Review qualification packages for completeness and accuracy, sound rationale, compliance with validation policies and procedures, and accurate data analysis.
- Compare results against acceptance criteria and work with appropriate departments to resolve exceptions and deviations.
- Bring critical exceptions or deviations to management's attention and propose compliant solutions.
- Lead trouble shooting activities for E-Beam deviations and non-conformances
- Recommend to management as to the acceptance and release of qualified systems.
- Initiate and enforce necessary improvements and corrections; attend team meetings pertinent to validation.
- Write and revise standard operating procedures describing validation principles and activities.
- Provide E-Beam training and guidance to applicable operators and technicians
- Establish priorities and schedule activities to ensure timelines and milestones are met.
- Oversee contractors ensuring that they have the appropriate skill set and required training and are meeting performance expectations.
Here is some of what you'll need (required)…
- B.A. or B.S. in Microbiology, Engineering, Chemistry, or related field
- Minimum 6 years of experience in sterilization experience.
- Knowledge of the regulatory and cGMP regulations for medical device manufacturing operations, and validation procedures and practices.
- Demonstrated ability to develop and present site-wide training sessions.
- Demonstrated knowledge of E-Beam sterilization science.
- Knowledge of statistics.
Here are a few examples of what you'll get for the great work you provide…
- Full range of medical benefits, dental, vision
- Life Insurance
- Matching 401K
- Tuition Reimbursement
- Employee discounts at local retailers
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