BD (Becton, Dickinson and Company) Site Validation Leader in Broken Bow, Nebraska
Job Description SummaryThe 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.
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.
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.
Becton, Dickinson and Company is an EqualOpportunity/AffirmativeAction 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 LocationUSA NE - Broken Bow
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.