Job Description Summary

Job Description

In our Quality team, we collaborate on a large scale, focusing on making sure everything is correct, effective and efficient to bring the highest-quality and most competitive products and services to our customers and their patients.

This position is a limited term assignment which will include benefits such as (medical, health, dental, 401k). Eligibility for these benefits will be based on the eligibility requirements as determined by the BD Total Rewards policy, and is anticipated to last approximately through March 31, 2022.

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:

• B.S. in Engineering field or equivalent

• 1 - 5 years of process development and/or Quality technology experience.

• 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.

• Ability to work with and motivate personnel.

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.

At BD, furthering Inclusion and Diversity is not just the right thing to do—it is both a cultural priority and a strategic imperative. One of the many reasons people choose to work at BD is for our comprehensive Total Rewards program aimed at the varying needs of our diverse and global associates. Total Rewards at BD includes base pay, incentives and benefits that support your health and wellness, family, money and lifestyle.

100% of day spent indoors.

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