CSV Engineer

• Develop and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for various computer systems and software applications.
• Work collaboratively with IT, Quality Assurance, and Operations teams to ensure adherence to regulatory guidelines and internal policies.
• Conduct risk assessments and impact analyses to identify critical system functionalities and potential vulnerabilities.
• Create and maintain comprehensive validation documentation, including validation plans, test scripts, traceability matrices, and validation summary reports.
• Perform periodic reviews to ensure ongoing compliance.
• Participate in change control processes, assessing the impact of system changes and overseeing appropriate validation activities.
• Provide expert guidance and support to project teams on CSV principles, best practices, and regulatory expectations.
• Stay up-to-date with industry trends, regulatory changes, and advancements in computer system validation.
• Collaborate with vendors and suppliers to ensure third-party systems meet validation requirements.
• Support regulatory inspections and audits, providing necessary documentation and participating in direct discussions.
• Perform qualification of laboratory analytical instruments (e.g., Cell Viability Analyzers, Liquid Handlers).
• Execute qualification of manufacturing automation systems (e.g., DeltaV, MES).

• Bachelor's degree in Computer Science, Engineering, or a related field.
• 5+ years of experience in computer system validation within a regulated industry, preferably pharmaceuticals or biotechnology.
• Strong knowledge of regulatory guidelines, including FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.
• Familiarity with various validation methodologies, including risk-based approaches.
• Proficiency in creating and executing validation protocols and documenting all validation activities.
• Excellent analytical and problem-solving skills, with a keen eye for detail.
• Strong communication and interpersonal skills for effective cross-functional collaboration.
• Ability to work independently and manage multiple projects simultaneously.
• Knowledge of Software Development Life Cycle (SDLC) and change control processes.
• Solid understanding of data integrity principles and practices.
• Experience with Sterile Drug Product manufacturing and associated equipment, utilities, laboratory instruments, and IT infrastructure enterprise systems.
• Proven experience in computer systems validation (CSV) from requirements through to release of SCADA / PLC controlled equipment (e.g., filling lines, isolators, Lyophilisers).
• Direct experience with Emerson DeltaV CSV.
• Proficiency in conducting Electronic Record Electronic Signatures (ERES) assessments and Data Integrity Risk Assessments for equipment/utility systems.
• Experience using paperless validation and test tools such as ValGenesis, Kneat, or ALM is highly desirable.

Morgan McKinley