Sterilization Engineer I

Título del trabajo: Sterilization Engineer I

Compañía: Smith & Nephew

Descripción de funciones: Sterilization Engineer I (Coyol, Alajuela)Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.Plan, develop, and control product monitoring processes including bioburden, bacterial endotoxin, and dose audit testing; as well as identify, plan, and support continuous improvement or new transfer projects.Job level (for internal use only): P1What 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?Education:

• Microbiologist, Biotechnologist, Chemical Engineer, Materials Engineer, or related title in similar careers on biological/chemical field.

Experience:

• Desirable at least 1 year of experience in similar positions.
• Experience in regulatory standards, reference standards, guidelines for microbiological testing, sterilization validations/maintenance, and microbiological evaluation of medical devices.

Competencies:

• Desired knowledge and understanding of quality system regulations/requirements (i.e. ISO 11137, ISO 13485, ISO 11135, ISO 11737, ISO 17025, 21 CFR Part 210/211, Part 820, and cGMP/GLP and USP.
• Knowledge of the validation process.
• Knowledge of bioburden and endotoxin determination assays and methodologies.
• Desired knowledge in EO and/or Radiation sterilization methodologies.
• Advance command of the English language.
• Ability to perform technical tasks independently.
• Ability to perform multiple tasks and ability to effectively manage conflict.

You. UnlimitedWe 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 more professional roles), flexible schedules.
• Training: Training program, unlimited learning.
• Extra perks: employees association, and more…

#LI-ONSITEStay connected and receive alerts for jobs like this by joining our .We’re more than just a company – we’re a community! Follow us on to see how we support and empower our employees and patients every day.Check our for a glimpse behind the scenes and a sneak peek into You. Unlimited., life, culture, and benefits at S+N.Explore our and learn more about our mission, our team, and the opportunities we offer.

Ubicación: Alajuela

Fecha del trabajo: Thu, 15 Aug 2024 06:44:38 GMT


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