Validation Technician
STERIS
El Coyol, A, CR
hace 5 días

Description

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.

Position Summary

Validation Technicians are responsible for the entire production validation process at their modalities. This includes Customer qualification of products and validation of the sterilization process in accordance with established procedures.

They work closely with the TechTeam or the Customer to assure the protocols are executed with care and are documented properly.

Generates accurate records including protocols and reports evidencing completion of these activities.

Duties

1. Maintains proper function of data collection devices used in validations and qualifications per procedure requirements.

2. Executes instrument calibrations per established procedures.

3. Executes Customer validations for routine production processing and those for dose audits or engineering studies. Generates study documentation.

Supports processing of Customer experimental samples including dose audits.

4. Executes product validations as scheduled.

5. Operates processing vessels, irradiators and / or electron beam equipment on Customer product.

6. Ensures processes are maintained in a validated state by executing revalidations following changes as well as performing periodic verifications.

7. Investigates unexpected test results and proposes solutions to process deviations and Customer complaints. Supports updates to procedures related to their responsibilities.

8. Contributes to safe and accurate processing by notifying Manager of any event, item or documentation that may have a concern in regard to regulatory or specification compliance, Customer product quality, or employee safety.

9. Assists in the performance and adherence to ISO requirements.

  • 10. Strives for continuous improvement by analyzing new or alternative ways to improve operations; incorporates recommendations into analysis;
  • responds to audit activities in a constructive manner and uses findings to improve operations where possible.

  • 11. Contributes in a team effort by performing in accordance to all STERIS policies, GMP, Lean principles and other directives;
  • supports the directives and decisions of higher-level management and performs other duties as assigned.

    Duties - cont'dEducation DegreeHigh School Diploma or GEDRequired Experience

    STERIS plc is a $3B, publicly traded (NYSE : STE) organization with more than 12,000 employees worldwide.

    STERIS strives to be an Equal Opportunity Employer.

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