Associate II, Manufacturing Science & Technology Engineering

Alcon•Houston, TX

1d•Onsite

About The Position

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 Associate II, Manufacturing Science & Technology Engineering, you will be trusted to work on developing, implementing, and evaluating new production materials, equipment, and technologies. You will conduct research, perform feasibility tests, and collaborate with vendors and partner functions, requiring advanced technical knowledge and problem-solving skills at our Manufacturing Facility in Houston, TX!

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

Nice To Haves

Previous Ethylene Oxide (EO) and Gamma sterilization experience.

Responsibilities

Investigate and identify the sterilization failures at ethylene oxide (EO) 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 implement 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).
Devise and implement methods and procedures for EO and Gamma sterilization.
Design and analyze sterility testing processes, mechanisms and equipment; conduct quality assurance tests.
Perform statistical analyses 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.