At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you'll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers.
We foster an inclusive culture and are looking for diverse, talented people to join Alcon. As an Engineer II - Sterilization supporting our Quality Assurance Engineer Team, you will be trusted to review and approve product manufacturing and Ethylene Oxide (EO) and Gamma sterilization batch records to ensure compliance with applicable SOPs and cGMP regulations at Houston, Texas US.
In this role, a typical day will include:
- Investigate and identify the sterilization failures at ethylene oxide and gamma contract sterilization facilities to ensure true root cause (CAPA) 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 (bioburden and sterility), new raw materials, packaging components and vendor qualifications.
- Develop, plan and execute annual ethylene oxide sterilization requalification. Develop and evaluate new components based on bioburden, packaging and functionality for adoption into EO or gamma family.
- Support the development, review and approval of sterilization process (parametric requirements, DEO, SLR, cycle calculation etc.,) for validation/qualifications (IQ, OQ & PQ).
- Devises and implements methods and procedures for Ethylene Oxide (EO) and Gamma sterilization.
- Designs and analyzes sterility testing processes, mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess control and manage risks of product quality and determine the responsibility for products or materials that do not meet required standards and specifications.
- Assist in external sterilizer audits to assure compliance with 21 CFR, ISO 13485 and Pharmaceutical Industry GMPs. Interpret & Apply ISO 11135, 11137, TIR 15, TIR 28, 11737 and FDA and Country specific guidelines to the medical devices and surgical.
WHAT YOU'LL BRING TO ALCON:
- 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
- Work hours: Monday through Friday - from 8:00am - 5:00pm
- Travel Requirements: 0 to 10%
- Relocation assistance: No
- Sponsorship available: No
HOW YOU CAN THRIVE AT ALCON:
- Collaborate with teammates to share standard processes and learnings as work evolve
- See your career like never before with focused growth and development opportunities
- Join Alcon's mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!
- Alcon provides robust benefits package including health, life, retirement, flexible time off for exempt associates; PTO for hourly associates, and much more!
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Alcon
flex time, relocation assistance
Sep 05, 2024