Job Description Summary
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Durante más de 125 años, hemos buscado nuestro propósito impulsando
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prometedor mediante el desarrollo de tecnologías, servicios y soluciones
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y la pasión de todos nosotros en BD, desde la manufactura al marketing
de nuestros productos, para ver lo imposible y encontrar soluciones
transformadoras que convierten nuestros sueños en posibilidades - para
las personas hoy, mañana y en un futuro. Sé un creador de lo posible
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Job Description

POSITION TITLE: SITE VALIDATION LEADER (SVL)

SCOPE:

The Site Validation Leader is responsible for execution and implementation of Validation initiatives at the site. Additional responsibilities include developing and maintaining the Validation Master Plan, train and educating associates and developing a validation support structure and document handling system. Each site has responsibility for tracking and reporting metrics associated with validation activities. Validation Leader is also responsible for setting goals related to the continuous improvement of the validation process, with tracking of key metrics.

DUTIES AND RESPONSIBILITIES:

• Local Implementation of Validation Toolkits
• Publish site specific progress, Reports and metrics
• Develop and maintain Validation Master Plan (VMP)
• Develop and maintain Validation Tracking Schedule (VTS)
• Maintain validation shared drive with Corporate
• 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 needs 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 Validation Core Team, Unit Program Managers and Unit Validation Champions
• Develop and maintain validation procedures and related local records
• Review and Approve protocols and reports as needed
• Develop and maintain metrics to measure progress
• Work with Corporate Validation Services to sustain validation activities
• Participate with the unit validation 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 techniques in validation efforts
• Mentoring and/or training in technical elements of validation such as Risk Analysis, MSA and DOE.
• Support site change control procedures
• Participate in management review and Executive Steering Committee to report on Validation Status
• Comply with all local, state, federal, and BD safety regulations, policies, and procedures.
• Ensure compliance with all applicable Regulations and Standards as defined in BD Quality, Safety and Environmental Manual and enterprise I.T. systems.
• Other duties as assigned

EDUCATION:

• Green Belt / Black Belt on Six Sigma Training
• 2 years Process Validation Experience
• Process validation training /experience
• Knowledge of Lean and Six Sigma for Manufacturing
• QSR/Manufacturing/Quality experience
• Process development experience
• Knowledge of analytical and statistical tools
• Knowledge of site processes

EXPERIENCE:

• Industrial Engineer or equivalent
• Six Sigma Certification (Green Belt Level) or CQE Certification
• Process Validation Certification

Skills:

• Strong knowledge on validation activities
• Strong knowledge on Statistical tools
• Strong technical, problem solving, and statistical background
• Effective communication skills
• Project Management skills
• Training and education skills
• Set priorities among multiple task
• Demonstrate effective leadership
• Develop validation skills across site
• Standardize Validations (Classifications and definitions)

Establish, maintain and communicate metrics.

Primary Work Location
MEX Nogales North - Luis Donaldo Colosio Blvd

Additional Locations

Work Shift