Senior Validation Engineer
Cencora
Senior Validation Engineer role supporting computer system validation in pharmaceutical healthcare. Candidate will lead validation processes, develop compliance documentation, conduct testing protocols, and collaborate with cross-functional teams to ensure regulatory adherence.
Responsibilities
- Lead gathering of business requirements and system integration design with gap identification
- Prepare and execute validation protocols including plans, protocols, and summary reports
- Conduct risk assessments, evaluate mitigation strategies, and manage defect resolution
- Collaborate with project managers, business owners, and cross-functional teams on validation strategy
- Train validation test teams on validation methods and review test case execution
Requirements
- Bachelor's degree in Computer Science, Engineering, or related field (or Master's with less experience)
- Five years of experience with Electronic Document Management Systems and validation protocols
- Pharmaceutical healthcare industry experience with FDA 21 CFR Part 11 and GxP compliance
- Proficiency writing SQL queries in Microsoft relational databases
- Experience with validation documentation including IQ/OQ/PQ protocols and Requirement Traceability Matrix
- Knowledge of test documentation tools and defect tracking systems
Vacancy posted 7 days ago
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