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Engineer II - Sterilization
Houston, TX
Job Description
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.
Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information. Equal Employment Opportunity Posters: If you’d like to view a copy of the Alcon’s affirmative action plan or policy statement, please email alcon.er@alcon.com.
EEO Statement: Alcon is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status.
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!
Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information. Equal Employment Opportunity Posters: If you’d like to view a copy of the Alcon’s affirmative action plan or policy statement, please email alcon.er@alcon.com.
EEO Statement: Alcon is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status.
Job Summary
Company
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
2+ years
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