BD (Becton, Dickinson and Company) Site Validation Leader, Staff Quality Engineer I in Sandy, Utah
Job Description SummaryThe Site Validation Leader is responsible for execution and implementation of validation initiatives at the site. Additional responsibilities include maintaining the Validation Master Plan, training and educating associates, and developing a validation support structure. The Site Validation Leader is also responsible for setting goals related to the continuous improvement of the validation process and tracking key metrics.
Ensures site is trained to BD validation guidelines and best practices.
Publish site-specific progress reports and metrics. Liaison to Corporate Validation Services.
Maintain local validation procedures and schedule (Validation Master Plan).
Maintain validation scheduling database.
Provide support to validation practitioners by providing guidance regarding assembling an appropriate team and strategy development.
Create and lead training and educational sessions appropriate for all associates participating in validations.
Ensure site is aware of upcoming validation training courses.
Mentor associates on process, software, and equipment validations. Lead process to improve effectiveness of validation work through mentoring, peer reviews, and audits.
Support and influence change management and change control procedures at site.
Develop and maintain local validation procedures and forms.
Mentoring and training in technical elements of validation such as risk analysis, measurement system analysis, and design of experiments.
Participate in management review and executive steering committee meetings to report on validation status.
Participate in regulatory audits.
Comply with all local BD quality policies, procedures, and practices through consistent application of sound quality assurance principles.
Other duties as assigned.
Annual validation goals
Develop validation skills across site
Establish and maintain subject matter expert group
Ensure procedure harmonization
Standardize validations (classification & definitions)
Train and execute
Incorporate various types of validation into the culture mainstream
Establish, maintain, and communicate metrics
EDUCATION AND EXPERIENCE REQUIREMENTS
BS degree in mechanical, manufacturing, or electrical engineering or a related science field.
A minimum of 8 years relevant experience or a combination of equivalent education and relevant experience.
Experience and training in design of experiments and statistics.
Six Sigma Green Belt or Certified Quality Engineer strongly preferred.
Two years process validation for medical devices experience.
Class II / III medical device experience or pharmaceutical experience preferred.
Project management skills, process validation training, and process validation experience.
Strong technical, problem solving, and statistical background.
QSR / Manufacturing / Quality experience.
Primary Work LocationUSA UT - Sandy
Work ShiftNA (United States of America)
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