Flex Job - 30156728 | CareerArc
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Company: Flex
Location: Austin, TX
Career Level: Mid-Senior Level
Industries: Technology, Software, IT, Electronics


Job Description

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
  • PTO
  • Tuition Reimbursement
  • Employee discounts at local retailers
Job Category OperationsFlex does not accept unsolicited resumes from headhunters, recruitment agencies or fee based recruitment services. Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. Flex does not discriminate in employment opportunities or practices based on: age, race, religion, color, sex, national origin, marital status, sexual orientation, gender identity, veteran status, disability, pregnancy status or any other status protected by law. Flex provides reasonable accommodation so that qualified applicants with a disability may participate in the selection process. Please advise us of any accommodations you request to express interest in a position by e-mailing: accesibility@flextronics.com. Please state your request for assistance in your message. Only reasonable accommodation requests related to applying for a specific position within Flex will be reviewed at the e-mail address. Flex will contact you if it is determined that your background is a match to the required skills required for this position. Thank you for considering a career with Flex.

The information we collect:

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If you have any queries about the processing of your data, please contact:

Global Data Privacy Officer:

Email Address: chiefprivacyofficer@flex.com

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