Position Summary

We are seeking an experienced Computer Systems Validation (CSV) Engineer/Specialist to support validation activities for computerized systems used in regulated pharmaceutical and biopharmaceutical environments. The ideal candidate will have hands-on experience with Computer Systems Validation (CSV), preferably involving MODA and/or LabWare systems, and a strong understanding of GxP, GAMP 5, 21 CFR Part 11, and validation lifecycle management.

This role is responsible for developing and executing validation documentation, ensuring regulatory compliance, validating system interfaces and data integrity, and collaborating with cross-functional teams to deliver compliant computerized system implementations.

Key Responsibilities

Computer Systems Validation

• Develop, review, and execute Computer Systems Validation (CSV) documentation throughout the validation lifecycle.
• Author and maintain Validation Plans (VP), User Requirement Specifications (URS), Operational Qualification (OQ), Performance Qualification (PQ), Validation Summary Reports (VSR), and Traceability Matrices (TM).
• Ensure validation activities comply with cGMP, GAMP 5, 21 CFR Part 11, Annex 1, and applicable regulatory requirements.
• Support system release and readiness for production use.

Validation & Testing

• Develop and execute validation protocols for computerized systems.
• Design and manage manual and automated test scripts within ALM or similar validation management tools.
• Perform regression testing to verify that new configurations do not impact existing functionality.
• Validate system interfaces, data transfers, and electronic records.

Data Integrity & Interface Validation

• Validate secure data transfer and mapping between laboratory instruments and computerized systems.
• Verify data integrity and traceability throughout system interfaces.
• Ensure accurate system configuration and data migration activities.
• Support validation of laboratory information management systems (LIMS) and manufacturing systems.

Defect & Change Management

• Document, investigate, and manage validation deviations and defects.
• Perform root cause analysis and support corrective actions.
• Collaborate with Quality teams to resolve validation issues.
• Support change control activities associated with validated systems.

Cross-Functional Collaboration

• Partner with Quality Assurance, Quality Control, Project Management, IT, Engineering, and Business SMEs.
• Translate business requirements into compliant validated system solutions.
• Participate in project planning, execution, and implementation activities.
• Provide technical guidance during validation projects.

Required Qualifications

• Bachelor's degree in Engineering, Computer Science, Information Technology, Biological Sciences, or another technical discipline.
• Equivalent combination of education and relevant experience will be considered.
• Minimum 5 years of experience in the pharmaceutical or biopharmaceutical industry.
• Hands-on experience with Computer Systems Validation (CSV).
• Experience validating laboratory or manufacturing computerized systems.
• Strong knowledge of validation lifecycle methodologies.
• Excellent written and verbal communication skills.
• Strong analytical and problem-solving abilities.
• Ability to work collaboratively across multiple functional teams.