Associate II, Manufacturing Science & Technology Engineering

SwiftCruit; Houston (TX); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Flexible time off

Job summary

Alcon in Houston, TX is seeking an Associate II in Manufacturing Science & Technology Engineering to develop and implement production materials and sterilization processes. This role requires advanced technical skills and collaboration with vendors to ensure product quality and compliance with industry standards.

The ideal candidate holds a Bachelor’s Degree or equivalent experience and possesses strong problem-solving and statistical analysis skills. Join Alcon to contribute to innovative eye care solutions and enjoy a robust benefits package.

Qualifications

• Bachelor’s Degree or Equivalent years of directly related experience.
• Ability to fluently read, write, understand, and communicate in English.

Responsibilities

• Investigate and identify sterilization failures at EO and gamma facilities.
• Perform risk assessments to determine criticality of CAPA.
• Review engineering protocols related to product tests and vendor qualifications.
• Implement ethylene oxide sterilization requalification.
• Design and analyze sterility testing processes.
• Conduct quality assurance tests.

Skills

Investigative skills

Statistical analysis

Technical problem-solving

Communication skills

Education

Bachelor’s Degree or Equivalent experience

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.

Associate II, Manufacturing Science & Technology Engineering

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.

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.

Qualifications

• 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

Preferred Qualifications

• Previous Ethylene Oxide (EO) and Gamma sterilization experience.

Benefits

Alcon provides a robust benefits package including health, life, retirement, flexible time off, and much more.

How You Can Thrive at Alcon

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.

Equal Opportunity Employer

ALCON IS AN EQUAL OPPORTUNITY EMPLOYER AND PARTICIPATES IN E-VERIFY. Alcon takes pride in maintaining an inclusive environment that values different perspectives and our policies are non-discriminatory in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, 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 [e-mail] and let us know the nature of your request and your contact information.