Sterilization Engineer I (Coyol, Alajuela)
Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.
Are you passionate about ensuring the highest standards of product safety and quality? Join our team as a Sterilization Engineer, where you'll plan, develop, and control product monitoring processes including bioburden, bacterial endotoxin, and dose audit testing; as well as identify, plan, and support continuous improvement activities and new transfer projects.
Job level (for internal use only): P1
What will you be doing?
Validate, execute, maintain, and improve microbiological testing on finished products. This includes, but is not limited to the implementation, development, and validation of testing methods such as bioburden, test of sterility, bacteriostasis & fungistasis, and endotoxin testing.
Supports and executes sterilization validations and requalifications including the coordination with the applicable sterilizer and dunnage preparation.
Coordinates microbiology-related tests for in-house or external laboratory execution ensures compliance with the specifications and collaborates with the success of the validations.
Assess product adoptions using applicable internal procedures and documentation.
Perform periodic sterilization process and product testing reviews.
Identify, plan, and execute sterilization, microbiology lab processes, and critical system testing improvement projects.
Assists/performs internal/ external audits as required.
Assists Clean Room Specialist tasks as applicable, including the review/verification of their execution/reports and performance.
What will you need to be successful?
Required:
Bacherlor's Degree in Microbiology, Biotechnologiy, Chemical Engineering, Materials Engineering, or a related field within the biological or chemical sciences.
Fluent in English (C1 or above preferred).
Knowledge of regulatory standards, reference standards, guidelines for microbiological testing, sterilization validations/maintenance, and microbiological evaluation of medical devices.
Knowledge of bioburden and endotoxin determination assays and methodologies.
Desirable:
At least 1 year of experience in similar positions
Knowledge and understanding of qualitysystem regulations/requirements (i.e. ISO 11137, ISO 13485, ISO 11135, ISO 11737, ISO17025, 21 CFR Part 210/211, Part 820, and cGMP/GLP andUSP.
Knowledge of validation processes.
Knowledge in EO and/or Radiation sterilization methodologies.
Competencies:
Ability to perform technical tasks independently.
Ability to perform multiple tasks.
Ability to effectively manage conflict.
You. Unlimited
We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.
Inclusion, Diversity, and Equity- Committed to Welcoming, Celebrating, and Thriving on Diversity, Learn more about Employee Inclusion Groups on our website.
Other reasons why you will love it here!
Your future: stock purchase program, referral bonus, subsidy in transport and food, recognition program.
Work/Life Balance: Extra days off, birthday off, voluntary hours.
Your Wellbeing: company doctor, medical insurance, gym, health campaigns, employee assistance program, parental leave.
Flexibility: Hybrid work model (for most professional roles), flexible schedules.
Training: Training program, unlimited learning.
Extra perks: employees association, and more…
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