Qualifications

• Bachelor's degree in engineering, Computer Science, Life Sciences, Pharmacy, Biotechnology, or related field.
• 3+ years of Computer System Validation (CSV) experience in a regulated pharmaceutical, biotechnology, or medical device environment.
• Knowledge of GAMP 5, FDA 21 CFR Part 11, GMP, and robust Data Integrity (ALCOA+) principles.
• Experience with validation documentation and testing activities.
• Familiarity with electronic quality management and document management systems.
• Strong technical writing and communication skills.

Responsibilities

• Execute and support Computer System Validation (CSV) activities for GxP systems.
• Develop, review, and maintain validation documentation including Validation Plans, URS, FS, Risk Assessments, IQ/OQ/PQ Protocols, and Validation Reports.
• Perform system impact assessments and implement risk-based validation activities.
• Support testing activities, including executing protocols and tracking defects.
• Ensure compliance with FDA regulations and Data Integrity requirements.
• Collaborate with cross-functional teams through the system lifecycle.
• Support change controls, deviations, CAPAs, and periodic reviews.
• Maintain validation records within electronic document management systems.
• Participate in internal audits and regulatory inspections.

Benefits

• Opportunity to work in a GxP-regulated environment with a focus on compliance and quality.
• Engagement in diverse collaboration with Business, IT, QA, and Engineering teams.
• Involvement in system lifecycle management and regulatory inspections.
• Access to electronic quality management systems, enhancing knowledge and experience.
• Development of comprehensive validation documentation skills.