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.
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
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
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 firstname.lastname@example.org