Alcon · 14 hours ago
Sr. Sterilization Engineer
Houston, TX
Full-time
Onsite
Mid, Senior Level
2+ years expAlcon is a global leader in eye care dedicated to helping people see brilliantly. The Sr. Sterilization Engineer will develop, implement, and evaluate new production materials and processes, ensuring compliance with industry standards and addressing production issues to maintain product quality.
Health CareManufacturingMedical Device
No H1B
Responsibilities
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
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
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
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
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
Qualification
Required
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
Work Hours: Monday – Friday, 8:00 AM – 5:00 PM CST
Location: Onsite
Travel Requirements: 0 – 10%
Relocation Assistance: None
Sponsorship Available: No
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
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
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
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
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
Preferred
Strong knowledge of EO, Gamma, E-Beam and X-ray sterilization modalities
Project Management
Benefits
Health and life insurance
Retirement
Flexible time off for exempt associates
Paid time off for hourly associates
And much more!
Company
Alcon
Alcon specializes in developing and manufacturing innovative medicines and devices to serve the cycle of eye care.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
unknown2010-12-15Acquired
2002-03-21IPO
Leadership Team
David Endicott
Chief Executive Officer
Tim Stonesifer
Chief Financial Officer
Recent News
Business Wire
2026-01-07
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