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Abbott Validation Engineer I in San Diego, California

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.

Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.

The position of Validation Engineer is within our Cardiometabolic business unit located at Abbott San Diego in San Diego, California. This position will manage a wide variety of technical tasks and projects to ensure manufacturing processes. This position is responsible for ensuring validations are addressed according to the validation plan, GMP, ISO and current applicable guidelines.

This job description will be reviewed periodically and is subject to change by management.

RESPONSIBILITIES:

  • Leads formulation of validation strategies and plans for new products and process improvements at the feasibility stage to guide subsequent development and transfer planning;

  • Provides facilitation and technical leadership in the generation of project technical content, including specifications, studies, protocols and reports

  • Resolves and consults on complex issues, drives process improvements required. Interfaces with equipment, machines and processes as required for the optimization and execution of validation activities.

  • Provides subject matter expertise in the design, development and validation of equipment, processes, formulations and analytical test methods. Provides subject matter expertise on the validation process with understanding of equipment calibration, maintenance, pFMEA and site level validation master plans.

  • Ensure documentation is complete and meets defined requirements

  • Leads utilization of quantitative risk assessments in validation and project planning

  • Possesses a working application/knowledge of medical device regulatory requirements and standards.

  • Understands and is aware of the quality consequences which may occur from the improper performance of their specific job; has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities

  • Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices; build productive internal/external working relationships

  • Carries out duties in compliance with established business policies

  • Other duties as assigned, according to the changing needs of the business

MINIMUM QUALIFICATIONS | EDUCATION/EXPERIENCE:

  • BS degree in Engineering; or equivalent related field.

  • Minimum 10+ years related experience

PREFERRED QUALIFICATIONS:

  • Exposure to validation of in-vitro diagnostic device and medical device manufacturing processes.

  • Knowledge of analytical and physical test methods and their respective validations.

  • Comprehensive knowledge of validation documentation.

  • Knowledge of federal and other regulations governing medical device assembly and design, e.g. GMP, QSR, ISO and CMDR.

  • Strong verbal and written communication skills

  • Organized and detail oriented

  • Ability to work in a team environment

COMPETENCIES:

  • Continually develops his/her own skillset.

  • Actively develops a network to bring best solutions to the team or customer.

  • Proactively listens to internal /external customers and clarifies expectations.

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities. To request an accommodation, please contact your local HR department.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com

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