EO Analyst II

STERIS•Coon Rapids, MN

About The Position

The EO Analyst II is responsible for the activities related to EO operations including establishment of process parameters, program development, validations, cost reduction procedures, documentation and reporting as directed. Ensures effective communication with Customers, contract laboratories and AST associates. Provides project management and analytical support to the EO Technology Team Manager to ensure turnkey validation initiatives are efficiently and accurately delivered to Customers.

Requirements

Bachelor’s degree with minimum of three (3) years’ experience in EO operations, engineering, and/or cycle development medical device or pharmaceutical industry with a working knowledge in lab functions as they relate to EO product related procedures.
Will accept minimum of ten (10) years’ experience in lieu of degree.

Nice To Haves

Work experience with a working knowledge of microbiology and/or chemistry preferred.

Responsibilities

Consults with Customers and prospective Customers to establish process parameters for new products; develops new cycles for existing products to include applications for residue and cycle cost reduction; uses his/her thorough understanding of ANSI/AAMI methods to include ISO 11135 when representing the company or developing cycles or programs for Customers; uses his/her knowledge of medical device packaging and biological incubation procedural techniques when developing Customer programs and/or coordinating lab services.
Represents the Customer and coordinates the many separate increments of Customer services so that a high degree of quality and efficiency is maintained in processing the Customer’s products, paper, inquiries, etc.
Removes barriers that prevent the Customer, the plant, and the center from reaching common objectives. Represents the company when dealing with contract lab services.
Performs technical writing as needed to create protocols and /or reports which support STERIS Customers’ validated processes.
Gathers relevant data and develops cost analysis formatted as a proposal to client for turnkey processes that include cycle cost, consultation cost, preparation costs, as well as external laboratory cost.
Executes the design of a process to ensure validation of the sterilization process. This includes identification of responsibilities, ensuring compliance, and associated documentation. This also includes definition and providing key documentation and testing procedures.
Coordinates with microbiology and physical test laboratories, different departments within the Customer’s company, other AST plants, consultants and others who require assistance so that the Customer and AST initiate product processing at the earliest possible date and maintain open communications.
Performs analysis of data as required to support conclusions reported to Customers for the effectiveness of their sterilization processes.
Communicates with the site management daily to encourage the positive implementation of sound instructions, exchange of ideas, review of activities and paperwork and to initiate corrective actions as required.
Assists in programming and scheduling Customer loads through the EO test vessels as prescribed by the Customer’s specifications and AST Standard Operating Procedures.
Coordinates with Customers to develop a schedule for the center’s vessel and communicates this information to EO departmental associates.
Maintains professional skills, knowledge and abilities by attending educational workshops, reviewing professional publications and participating in professional societies.
Communicates in an effective manner by utilizing accepted business practices in a courteous and professional manner providing timely and accurate responses and service oriented offers of assistance.
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.