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Validation Engineer

Apply Now Job ID R-335022 Date posted 04/04/2019

Job Description Summary

Job Description

PURPOSE:  Ensures compliance through latex process validation conformance.  Facilitate the corrective action and failure analysis process.  Process delineation studies, design of experiments (DOE), validation remediation and statistical analysis.  Support internal documentation requirements. 

MAJOR DUTIES AND RESPONSIBILITIES:

  • Responsible for the execution or review of required validation activities supporting BDI initiatives.
  • Validate current and new products and processes.
  • Perform validation remediation as required.
  • Provide periodic updates of assigned validations and communicate identified roadblocks to QA/Ops Manager.
  • Participate in site validation strategy.
  • Provide input to site MVP and applicable project MVP.
  • Developes, updates and maintains site validation procedures and related records
  • Perform data integrity verification on assigned validation documents
  • Review and approve assigned validation documents as the QA engineer role
  • Assess operational control via audits and SPC techniques.  
  • Identify causal relationships between observed failures, complaints and current manufacturing techniques.  Product analysis and process evaluations are required to fulfill this requirement.
  • Draft appropriate documents to support the Quality systems.  Support the document control and project management systems.
  • Support drawing control systems regarding their quality requirements.
  • Perform all duties required for compliance with validation- related corporate  systems.
  • Make decisions on product/process quality based on evaluations.
  • Quality standards development.
  • Other duties as assigned by Supervisor.

EXPERIENCE / EDUCATION/TRAINING/SKILL REQUIREMENTS:

To perform this job successfully, an individual must be able to perform each essential job duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

  • B.S. in Engineering field or equivalent
  • Basic knowledge of statistics and  quality engineering techniques.
  • Experienced in validations, including but not limited to product, process, equipment, test methods, DOE, cleaning and software validations
  • Good technical writing skills for protocol generation.
  • Attention to detail
  • Good communication skills.
  • Experience in process improvements and automation.
  • Five years of process development and/or Quality technology experience.
  • Ability to work with and motivate personnel. 

PHYSICAL DEMANDS AND WORK REQUIREMENTS:

  • While performing the duties of this job, the employee is frequently required to stand; walk; use hands or arms (to finger, handle or feel objects, tools, or controls).  The employee is occasionally required to sit; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; and talk or hear.
  • The noise level in the work environment is normally quiet to moderate.
  • 100% of day spent indoors.

Primary Work Location

USA SC - Moncks Corner

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