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Sterilization Engineer

1 month ago

Houston, Texas, United States Alcon Full time
About the Role

We are seeking a highly skilled Sterilization Engineer to join our Quality Assurance team at Alcon. As a key member of our team, you will be responsible for reviewing and approving product manufacturing and sterilization batch records to ensure compliance with applicable SOPs and cGMP regulations.

Key Responsibilities
  • Investigate and identify sterilization failures at ethylene oxide and gamma contract sterilization facilities to ensure true root cause is identified and documented within the Quality System.
  • Perform risk assessments to determine criticality of the CAPA.
  • Determine overall product quality by reviewing and evaluating engineering protocols related to product tests, new raw materials, packaging components, and vendor qualifications.
  • Develop, plan, and execute annual ethylene oxide sterilization requalification.
  • Support the development, review, and approval of sterilization processes for validation/qualifications (IQ, OQ & PQ).
  • Design and implement methods and procedures for Ethylene Oxide (EO) and Gamma sterilization.
  • Design and analyze sterility testing processes, mechanisms, and equipment; conduct quality assurance tests; and perform statistical analysis to assess control and manage risks of product quality.
  • Assist in external sterilizer audits to assure compliance with 21 CFR, ISO 13485, and Pharmaceutical Industry GMPs.
Requirements
  • Bachelor's Degree or Equivalent years of directly related experience (or high school +8 yrs; Assoc.+4 yrs)
  • The ability to fluently read, write, understand, and communicate in English
What You'll Bring to Alcon

As a Sterilization Engineer at Alcon, you will have the opportunity to work with a talented team of professionals who are passionate about delivering high-quality products and solutions to improve sight and improve lives. You will be recognized for your commitment and contributions, and you will have the opportunity to see your career like never before with focused growth and development opportunities.

Alcon provides a robust benefits package, including health, life, retirement, flexible time off for exempt associates, and PTO for hourly associates. We foster an inclusive culture and are looking for diverse, talented people to join our team.