Responsibilities:

1. Execute pharmaceutical CSV validation projects including implementation of new systems, remediation of legacy systems, and re-validation activities
2. Develop and execute validation deliverables including Validation Master Plans, IQ/OQ/PQ protocols, summary reports, and impact assessments
3. Coordinate with validation, engineering, IT, and quality teams to ensure successful project execution
4. Lead cross-functional teams in development and execution of validation activities
5. Generate and review system impact assessments and critical aspect assessments
6. Engage end users for URS/FRS documentation generation and testing requirements
7. Develop and execute test scripts while supporting troubleshooting and system configuration activities
8. Manage multiple CSV projects utilizing project management methodologies
9. Support development of validation best practices aligned with current industry standards and guidelines
10. Ensure compliance with applicable SOPs, safety procedures, and regulatory requirements

Requirements:

1. Bachelor’s Degree in Computer Science, Engineering, or related field
2. Minimum 3 years of Computer System Validation experience within a pharmaceutical or biotech environment
3. Strong understanding of FDA, EU compliance regulations, and GAMP guidelines related to CSV
4. Experience with computerized system lifecycle validation deliverables
5. Experience with ERP systems, EQMS systems, PLC/SCADA, DCS, laboratory instrumentation, or process automation technologies
6. Familiarity with off-the-shelf, configurable, and custom-developed applications
7. Experience within pharmaceutical manufacturing environments preferred
8. Proficiency with Microsoft Office and quality systems software
9. Strong communication and cross-functional collaboration skills