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Abbott Senior Specialist, Validation in Princeton, New Jersey

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 103,000 colleagues serve people in more than 160 countries.

POSITION OVERVIEW:

The Senior Specialist of Validation opportunity is an individual contributor with comprehensive knowledge in Software Validation and Data Integrity. This person will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving.

WORKING KNOWLEDGE OR EXPERTISE IN:

  • 21 CFR Part 820 / ISO 13485

  • 21 CFR Part 11

  • Software validation practices and Software Development Life Cycle (SDLC) models

  • Agile and Waterfall SDLC methodologies

  • Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems

  • Requirements analysis, Design analysis, Validation Plans, Configuration controls, and Source Code Repository controls

  • Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)

  • Software Risk Management Principles

  • Data Integrity Principles

CORE JOB RESPONSIBILITIES:

Main responsibilities include:

  • Develops and evaluates quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements

  • Writes, reviews, approves and/or executes documentation for new and current validation procedures and technical reports related to non-product computerized software validation (CSV) processes

  • All non-product computerized software validation (CSV) quality approvals

  • Perform pre and post review and approval of all SDLC project deliverables

  • Perform Risk Assessments

  • Investigates/troubleshoots validation problems for non-product computerized software validation (CSV) and/or performance processes

  • Responsible for providing guidance and support to project and/or base business support teams in the resolution of validation documentation corrections

  • Lead and mentor software system owners in the execution of SDLC project deliverables

  • Provide and present non-product computerized software validation (CSV) metric data at status meetings

  • Support internal and external regulatory audits and inspections

  • Conduct Data Integrity Assessments of non-product computerized software validation (CSV) systems

  • Conduct Periodic Reviews of non-product computerized software validation (CSV) systems to ensure compliance

  • May partner with/participate in Cybersecurity initiatives for non-product computerized software validation (CSV) systems

  • May assist with establishing corporate non-product computerized software validation (CSV) validation policies

MINIMUM QUALIFICATIONS:

  • Associates degree

  • Software Development Life Cycle (SDLC) experience and analysis

  • Risk Management/Assessment experience

  • Candidates will have experience utilizing basic negotiation, influencing and conflict management skills, will interact effectively with peers and leadership across departments and possess excellent interpersonal and communication skills

PREFERRED QUALIFICATIONS:

  • Knowledge of regulations and standards affecting In Vitro Diagnostics and Medical Devices (CFR 820) (e.g. ISO, FDA Quality System Regulations preferred).

  • Strong technical skills, e.g. technical writing

  • Data Integrity enforcement experience

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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