Sr. Sterilization Engineer

Alcon • Houston, TX

25d • 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 a Sr. Sterilization Engineer, you will be trusted to work on developing, implementing, and evaluating new production materials, equipment, and technologies before mass production. You will conduct research, solve production cost and quality issues, and develop standard manufacturing procedures, requiring advanced technical knowledge and analytical skills at our Manufacturing Facility in Houston, TX! In this role, a typical day will include: Sterilization Process Development & Validation Design and approve sterilization processes including EO parametric requirements, DEO, SLR and cycle calculations. Lead and execute validation activities (IQ, OQ, PQ) for EO and Gamma sterilization modalities. Design dose mapping studies for Gamma sterilization. Requalification & New Component Evaluation Develop and manage annual ethylene oxide (EO) sterilization requalification protocols and reports. Evaluate new components for sterilization compatibility based on animal tissue, microbiological and EO residues assessment. Quality & Compliance Review and assess engineering protocols related to microbiology and sterility testing, raw materials, packaging components, and vendor qualifications. Investigate sterilization failures at contract facilities, identify true root causes, and implement/track CAPAs within the Quality System. Technical Expertise & Risk Management Perform statistical analysis to assess process control and manage risks related to product sterility. Support design control activities with sterilization-related risk documentation. Design and analyze sterility testing and EO residue methods. Regulatory & Standards Compliance Support external audits of sterilization vendors to ensure compliance with 21 CFR, ISO 13485, and GMP requirements. Interpret and apply relevant standards and guidance documents including ISO 11135, ISO 11137, ISO 11737, AAMI TIRs (15, 17, 28), and FDA/country-specific regulations. Previous experience in EO and Gamma Sterilization modalities.

Requirements

• Bachelor’s Degree or Equivalent years of directly related experience (or high school +10 yrs; Assoc.+6 yrs; M.S.+0 yrs)
• The ability to fluently read, write, understand and communicate in English
• 2 Years of Relevant Experience

Nice To Haves

• Strong knowledge of EO, Gamma, E-Beam and X-ray sterilization modalities.
• Project Management.

Responsibilities

• Sterilization Process Development & Validation Design and approve sterilization processes including EO parametric requirements, DEO, SLR and cycle calculations. Lead and execute validation activities (IQ, OQ, PQ) for EO and Gamma sterilization modalities. Design dose mapping studies for Gamma sterilization.
• Requalification & New Component Evaluation Develop and manage annual ethylene oxide (EO) sterilization requalification protocols and reports. Evaluate new components for sterilization compatibility based on animal tissue, microbiological and EO residues assessment.
• Quality & Compliance Review and assess engineering protocols related to microbiology and sterility testing, raw materials, packaging components, and vendor qualifications. Investigate sterilization failures at contract facilities, identify true root causes, and implement/track CAPAs within the Quality System.
• Technical Expertise & Risk Management Perform statistical analysis to assess process control and manage risks related to product sterility. Support design control activities with sterilization-related risk documentation. Design and analyze sterility testing and EO residue methods.
• Regulatory & Standards Compliance Support external audits of sterilization vendors to ensure compliance with 21 CFR, ISO 13485, and GMP requirements. Interpret and apply relevant standards and guidance documents including ISO 11135, ISO 11137, ISO 11737, AAMI TIRs (15, 17, 28), and FDA/country-specific regulations. Previous experience in EO and Gamma Sterilization modalities.

Benefits

• Alcon provides a robust benefits package including health and life insurance, retirement, flexible time off for exempt associates, paid time off for hourly associates, and much more!

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level