CSV/CSA Consultant

Key Responsibilities:

SaaS & Enterprise System Validation:

• Validate and maintain cloud-based enterprise systems including Oracle Fusion Cloud ERP, serialization platforms (Tracelink, Antares), and electronic quality management systems
• Implement and validate Electronic Batch Record (EBR) systems such as MasterControl
• Support serialization system validation for end-to-end drug product shipping in compliance with DSCSA regulations
• Validate data migrations and integrations between enterprise systems (Oracle, Cardinal Health, Azure)
• Perform release impact assessments and testing for SaaS system updates
• Drive Computer Software Assurance (CSA)-based validation approaches for cloud systems

Equipment & System Qualification:

• Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for manufacturing and laboratory equipment
• Conduct Configuration Specification Verifications and periodic reviews for Autoclaves, Bioreactors, HPLCs, and other critical systems
• Qualify cell therapy and manufacturing equipment including controlled rate freezers, flow cytometers, and production systems
• Support commissioning and qualification of facilities, utilities, and Building Automation Systems (BAS)

Validation Documentation & Compliance:

• Author and execute validation protocols including Validation Plans, URS, FRS, IQ/OQ/PQ, RTM, and Validation Summary Reports
• Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and ALCOA++ data integrity principles
• Support change control management, deviations, and CAPA processes in GxP environments
• Perform SOP mapping and business process documentation for system implementations
• Maintain validation documentation in Electronic Document Management Systems (EDMS)

Inspection & Audit Readiness:

• Support regulatory inspection readiness by ensuring validation documentation is audit-ready
• Participate in internal and external audits, providing validation evidence and technical expertise
• Conduct data integrity assessments and implement controls to maintain compliance

Required Qualifications:

Education & Experience:

• Bachelor's degree in Engineering, Life Sciences, Computer Science, or related field
• 5-8+ years of hands-on Computer Systems Validation experience in pharmaceutical, biotechnology, or medical device industries

Technical Skills:

• Strong experience with Oracle Fusion Cloud ERP or similar enterprise ERP systems (SAP, Oracle E-Business Suite)
• Experience validating serialization systems (Tracelink, Antares) and DSCSA compliance highly preferred
• Hands-on experience with SaaS/cloud-based system validation and CSA approaches
• Equipment qualification experience (autoclaves, bioreactors, HPLCs, manufacturing equipment)
• Proficiency with electronic quality systems (MasterControl, Veeva Vault, TrackWise, ZenQMS)
• LIMS validation experience (LabWare, LabVantage, Empower)
• Strong knowledge of GAMP 5, 21 CFR Part 11, GxP, and data integrity principles

Core Competencies:

• Proven ability to author, review, and execute IQ/OQ/PQ protocols independently
• Strong understanding of risk-based validation and Computer Software Assurance (CSA)
• Experience with change control, deviation management, and CAPA processes
• Excellent documentation skills and attention to detail
• Strong communication and collaboration skills with cross-functional teams
• Ability to manage multiple priorities in a fast-paced GMP environment