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Job Details
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.
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 systems
- Lead periodic system performance, data integrity, and compliance assessments
- Review change controls, deviations, and CAPAs for compliant system operation
- Ensure completion and compliance of all periodic validation deliverables to regulatory and company standards
- Provide expert input on validation strategies, risk assessments, and remediation plans
- Liaise with QA, IT, and business stakeholders to plan and execute revalidation activities
- Support regulatory inspections and internal audits as the periodic validation SME
- Stay current with regulatory trends and guidance relevant to CSV and validation practices
- Oversee and implement the site validation master plan for processes, equipment, and system changes
- Ensure thorough documentation and coordination of validation activities and studies
- Support EHS (Environment, Health, Safety) requirements and continuous improvement initiatives
- Bachelor’s Degree (Level 8) in Science, Engineering or related discipline
- Thorough knowledge of cGMP and regulatory requirements
- Minimum 2 years’ experience in Validation within a regulated industry
- Strong understanding of computer system validation, qualification, and SCADA systems
- Experience with GAMP 5 categorization of computerized systems
- Ability to design/build validation plans from project concept to system end of life
- Knowledge of process validation, CPV, sterilization, and packaging systems
- Demonstrated interpersonal and communication skills for cross-functional teamwork
Preferred Qualifications:
- Strong, up-to-date understanding of data integrity expectations
- Experience leading large/complex projects with multiple stakeholders and vendors
- Agility to support multiple Commissioning, Qualification, and Validation (CQV) activities
- Ability to manage emergency changes while maintaining high GxP standards
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.
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