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Title:  Validation Specialist II

Req ID:  14995
Category:  Research & Development/Scientific
City:  Brooklyn Park
State:  MN
Postal Code:  55445
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.

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Position Summary

Develops, executes and prepares protocols and final reports of validation/qualification studies relating to steam, EO, radiation, dry heat and E beam sterilization, in-process cleaning, manufacturing laboratory testing for internal and external Customers, cleaning qualifications reusable medical devices, etc. Supports the Validation Manager with projects or assignments and provides consulting services to Customers as requested.

Duties

Sterilization Validation:

 

  • Participates in Technology Transfer and assists in identification of required validations and the preparation of Master Validation plans.
  • Preparess quotes, develop and execute protocols and prepare final reports for validation of sterilization, cleaning, manufacturing, and laboratory processes for internal and external customers. 
  • Performs continual evaluation of results generated during execution of validations to recommend adjustments for internal and external customers in a timely manner.
  • Coordinates activities related to Technology Transfer project assignments and reports updates and status into Technology Transfer.
  • Writes and revises or advises on affected procedures as necessary.
  • Ensures application of Biotest Quality System in all department activities.

 

Consulting

 

  • Consults with Customers to convey requirements of applicable domestic and international standards to Customer personnel in order to establish validation plans.
  • Consults with Customers regarding sterilization validation including microbial evaluations, interpretation of standards, evaluation of compliance, and responding to Regulatory Agency or Notified Body inquiries.

 

 

     Process/Equipment Validation (internal and external)

 

  • Provides support of existing manufacturing in determination of equipment relevant to support manufacturing operations with associated qualification validations.
  • Develops receiving, in-process, and final product inspection specifications and procedures for internal and client needs. 
  • Supports laboratory test method development and validations as requested.
  • Develops and maintain Validation workbook with recommendation of re-validation requirements.
  • Conducts process and equipment validations associated with manufacturing and laboratory services.

 

Duties - cont'd

 

 Documentation Review

 

  • Reviews calibration records to ensure that the results are within specified tolerances and ranges.
  • Assures Calibration and Maintenance activities performed are executed according to approved protocol, procedure, recommendation or other documented method.
  • Reports perceived or known issues with the functionality or operational capability of equipment based on data review.
  • Provides support to the Validation Manager through review of Customer validation protocols and final reports
  • Provides support to the Validation Manager through review of internal laboratory, sterilization, or manufacturing related protocol and final reports.
  • Reviews Cleanroom/Cleanbench records.
  • Reviews sterilization data generated during routine sterilization (technical review of device history records).
  • Provides back-up laboratory report review.

 

New Business Support:

 

  • Researches and evaluates proposed Quality Services to support company growth and continued provision of expert high quality services.
  • Supports implementation of approved improved processes through development or modification of validation protocols, execution of validations, generation of final reports, and interface with Customers.
  • Consults with internal and external Team members, as well as, other entities to assure identification of relevant issues, cost, and Quality Service System requirements.
  • Works with the Validation Manager and the project Team to assure development of methods for addressing issues and requirements.
  • Supports the development and evaluation of data and text relevant to company planned publications.

 

Quality System

 

  • Demonstrates understanding of Good Manufacturing Practices through continuous observation of the work environment and work practices of all employees, reporting observations and recommendations for improvement to appropriate staff in a timely manner.
  • Maintains compliance with Quality Management System procedures in all Quality System activities, assuring fully documented training has been completed prior to the execution of the activities.
  • Participates in all required training activities and associated comprehension assessments.
  • Evaluates procedures and provides process improvement suggestions through execution of Document Change Order (DCO) activities.
  • Initiates and executes Quality System Investigations, Customer Dissatisfactions and Corrective actions as required by procedure.
  • Participates in Regulatory, notified body and Customer audits as appropriate.

May receive training as an Internal/Supplier Auditor and execute associated responsibilities.

Education Degree

  • Bachelor's Degree

Required Experience

Minimum four years experience in a regulated industry.

  • Experienced in the development of validation protocols, management of the execution of validations, and in the writing of final reports.
  • Microbiological coursework and practical experience preferred.
  • Demonstrated capability to read, analyze and interpret technical procedures, governmental regulations, and industry standards.
  • Demonstrated capability to write reports, business correspondence and procedures.
  • Ability to lift and exert force of up to 25 lbs.
  • Color vision with the ability to accurately identify and distinguish colors.
  • Corrected vision to 20/20.
  • Effectively present information and respond to questions from managers, Customers, personnel, regulatory or notified body entities.
  • Apply advanced mathematical concepts and operation.
  • Proven ability to define problems, collect data, establish facts, and draw conclusions.
  • Proven ability to interface with internal and external individuals regarding factors relevant to manufacture of medical devices or pharmaceutical products.
  • Ability to work in a regulated environment that requires strict adherence to company policies and procedures.
  • Demonstrated ability to multi-task, problem solve and work well under pressure.
  • Ability to work well with others.
  • Demonstrated excellent Customer service skills.
  • Possesses exceptional organizational, time management, and documentation skills.

 

STERIS is a $2B+, publicly traded (NYSE: STE) organization with approximately 12,000 associates worldwide and operates in more than 100 countries.

If you need assistance completing the application process, please call 1 (440) 392.7047. This contact information is for accommodation inquiries only and cannot be used to check application status.

STERIS is an Equal Opportunity Employer.  We are committed to equal employment opportunity and the use of affirmative action programs to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law.  We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.

The full affirmative action program, absent the data metrics required by § 60-741.44(k), shall be available to all employees and applicants for employment for inspection upon request. The program may be obtained at your location’s HR Office during normal business hours.

Req ID:  14995
Category:  Research & Development/Scientific
City:  Brooklyn Park
State:  MN
Postal Code:  55445


Nearest Major Market: Minneapolis

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