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Site Validation Leader

Apply Now Job ID R-332132 Date posted 03/05/2019

Job Description Summary

The Site Validation Leader (SVL) is responsible for execution and implementation of Corporate and Unit validation initiatives at the site. Additional responsibilities include developing and maintaining the Validation Master Plan, training and educating associates and developing a validation support structure and document handling system. The SVL also will sometimes serve as a validation practitioner and provide leadership or support for other Quality initiatives. Each site has responsibility for tracking and reporting metrics associated with validation.

Job Description

  • The essential functions of this position include but are not limited to:
    • Local implementation of Validation Toolkit
    • Publish site specific progress reports
    • Develop and maintain Validation Master Plan (VMP)
    • Develop and maintain Validation Tracking Schedule (VTS) PPT
    • Ensure validation support structure and document handling system are developed and maintained
    • Host training and educational sessions appropriate for associates relevant to validation procedures.  Establish and maintain systems that track training and training records
    • Establish and maintain systems that track Validation records; i.e. protocols, completion reports, and total Validation Package
    • Establish mentoring process to improve effectiveness of validation work
    • Communicate site activities regarding validation
    • Support and influence change management at site:  Liaison between Core Team, Unit Program Managers, and Unit Validation Champions
    • Develop and maintain validation procedures and related local records
    • Maintain records of plant studies and MSA’s
    • Approve protocols and reports as needed
    • Develop and maintain metrics to measure progress
    • Work with Corporate Validation Services to sustain validation activities
    • Participate on Unit Validation Leader Team by attending bi-weekly conference calls and regular meetings
    • Participate in Regulatory Audits and inspections
    • If the SVL is also a Practitioner, use Lean, problem solving methods, and data analysis tools and technique in validation efforts
    • Support site change control procedures
    • Participate in Management Review and Executive Steering Committee to report on validation status
    • May drive or participate in other plant initiatives which align with strategic plant and quality goals
    • Develops and maintains the plant FMEA system
    • Supports plant Safety initiatives
    • Managerial duties may be assigned based on need or individual competencies.

Qualifications

  • B.S. or B.A. Degree in Science or Engineering field is required. 
  • Experience in Quality Assurance and/or Mathematics/Statistics could be used in lieu of education in Science or Engineering.
  • Process validation training Six Sigma or CQE certification (Green Belt Level) - strongly desired Working knowledge of statistical tools such as control limits, statistical process control, probability and trending, FMEA, and Measurement System Analysis.
  • Working knowledge of the Federal Regulations and International Standards pertaining to Medical Devices, and their application.

#LI-OPS

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status.

Primary Work Location

USA NE - Broken Bow

Additional Locations

Work Shift

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Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com