Quality Engineer - CSV & Quality Systems

We are seeking a Quality Engineer with experience in computerized systems validation and quality oversight within regulated pharmaceutical/life sciences environments. The role will support Quality Information Systems Management (QISM) initiatives across Manufacturing and Analytical Laboratory systems., * Provide quality oversight for enterprise and lab system projects including ServiceNow, QMS, ERP, Veeva, RIM, Manufacturing, and Lab Systems

• Support system validation activities including requirements, risk assessments, test scripts, execution, and traceability reviews
• Participate in change controls, deviations, CAPAs, periodic reviews, and system releases
• Ensure compliance with Data Integrity, GAMP5, and validation lifecycle
• requirements
• Collaborate with cross-functional teams to resolve quality and compliance issues
• Identify quality risks and support mitigation planning

• 6-10+ years of experience in CSV/CSA, Quality Systems, or Validation
• Strong knowledge of GAMP5, Data Integrity, ITIL, and SDLC/validation lifecycle
• Experience with enterprise systems, manufacturing systems, and lab applications
• Strong documentation, analytical, and communication skills

Preferred:

• Experience with Veeva VQMS, ServiceNow, ALM/e-signature systems
• Knowledge of Agile validation methodologies
• Bachelor's degree in IT, Computer Science, or related field