Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

The Validation Engineer plays a crucial role in ensuring the qualification and validation of all cGMP equipment, systems, and processes at the AbbVie Westport site. Reporting within the Validation Department, this position also serves as a Subject Matter Expert (SME) for Computer System Validation (CSV) Periodic Validation, leading reviews and revalidation of computerized systems to ensure continued compliance with FDA, HPRA, EU Annex 11, and GxP regulations. All activities must adhere to global standards and regulatory requirements.

Key Responsibilities:

Develop, maintain, and execute periodic validation and review plans for GxP-regulated computerized systemsLead periodic system performance, data integrity, and compliance assessmentsReview change controls, deviations, and CAPAs for compliant system operationEnsure completion and compliance of all periodic validation deliverables to regulatory and company standardsProvide expert input on validation strategies, risk assessments, and remediation plansLiaise with QA, IT, and business stakeholders to plan and execute revalidation activitiesSupport regulatory inspections and internal audits as the periodic validation SMEStay current with regulatory trends and guidance relevant to CSV and validation practicesOversee and implement the site validation master plan for processes, equipment, and system changesEnsure thorough documentation and coordination of validation activities and studiesSupport EHS (Environment, Health, Safety) requirements and continuous improvement initiatives
Qualifications
Bachelor’s Degree (Level 8) in Science, Engineering or related disciplineThorough knowledge of cGMP and regulatory requirementsMinimum 2 years’ experience in Validation within a regulated industryStrong understanding of computer system validation, qualification, and SCADA systemsExperience with GAMP 5 categorization of computerized systemsAbility to design/build validation plans from project concept to system end of lifeKnowledge of process validation, CPV, sterilization, and packaging systemsDemonstrated interpersonal and communication skills for cross-functional teamwork

Preferred Qualifications:

Strong, up-to-date understanding of data integrity expectationsExperience leading large/complex projects with multiple stakeholders and vendorsAgility to support multiple Commissioning, Qualification, and Validation (CQV) activitiesAbility to manage emergency changes while maintaining high GxP standards
Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html