Validation Engineer
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Job Location:
Monthly Salary:
Posted on:
6 hours ago
Vacancies:
1 Vacancy
Job Summary
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
Qualifications :
- Bachelors 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
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.
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No
Employment Type :
Full-time
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
About Company
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more
