Validation Analyst
Coyol, A, CR
hace 6 días

Position Summary

Assists in the processing of Customer products. Duties include coordinating production scheduling and performing product and equipment validations, calibrations and qualifications.

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


Essential Job Functions

40% Time allocated to position(Primary duties)

1. Contributes to the facility equipment commissioning and requalification according to standards.

2. Schedules and peforms product validations to determined standards.

20% Time allocated to position(Mixed)

  • 3. Contributes to the accurate and safe processing capability of the company by coordinating, scheduling and executing all Customer validations and dose mappings;
  • calibrates and maintains proper function of data collection devices used in validations and qualifications.

  • 4. Optimizes processing by coordinating scheduling of Customer product, assists plant management in training operations employees in performing process procedures;
  • assists operations as required to ensure the timely movement of product. May provide guidance and supervision to Operators and Material Handlers.

    5. Provides Customer service by assisting in the performance and adherence to ISO 11135 and ISO 11137 requirements.

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

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

    8. Issues monitoring devices in hazard areas as required by safety rules and laws.

    9. Exhibits a commitment to the AST shared values of Customer Satisfaction and Continuous Improvement through ensuring defect-free workmanship, assisting others to meet the Customer’s needs, searching for efficient and effective ways to reduce waste, being active and accountable for Customer satisfaction, and satisfying the Customer’s needs with a sense of urgency.

  • 10. Contributes in a team effort by performing according to the guidelines outlined in the STERIS Code of Business Conduct, the GMP, Lean principles and other directives;
  • supports the directives and decisions of higher level management and performs other duties as assigned.

    Required Experience

    Number of years experience accepted in lieu of degree and type : 5 Years EO Sterilization Technician

    Number of years experience with degree indicated above and type : 2 Years EO Sterilization Technician

    1. A minimum of 1 year of experience as an ethylene oxide technician and 2 years experience in a sterilization processing.

    2. Ability to effectively write and verbally communicate

    3. Ability to work independently under general guidelines and supervision.

    4. Effective interpersonal skills as demonstrated through prior management experience.

    5. Requires ability to navigate through defined computer screens.

    6. Above average organizing and analyzing skills and Level 2 math skills (four basic arithmetic functions in all units of measurement, decimals ratios, rates, percentages) to determine organizational, Customer and regulatory problems and formulate corrective action plans; attention to detail.

    7. Ability to adapt to changing duties and responsibilities.

    8. Normal hearing range sufficient to hear alarms, bells, horns, etc.

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