Sterilization Engineer II
3 weeks ago
As an Engineer II - Sterilization at Alcon, you will be responsible for reviewing and approving product manufacturing and Ethylene Oxide (EO) and Gamma 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 (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.
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
Work Environment:
Monday through Friday - from 8:00am - 5:00pm
Travel Requirements: 0 to 10%
Benefits:
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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