CSV Application Engineer

Job Description

• Responsible for CSV remediation and compliance activities related to computerized systems and equipment used in sterile manufacturing operations,


• Planning and implementing corrective, preventive, and improvement actions to ensure compliance with GMP and CSV requirements,


• Preparing, reviewing, and executing CSV documentation, including URS, FS/DS, Risk Assessments, Traceability Matrices, IQ/OQ/PQ protocols, and validation reports,


• Performing retrospective validation and gap assessment/remediation activities for computerized systems,


• Supporting lifecycle management activities, including periodic review, change control, deviation management, CAPA follow-up, backup verification, and audit trail review,


• Applying risk-based decision-making principles in validation and compliance activities,


• Providing technical and compliance support during customer and regulatory authority inspections,


• Coordinating with third-party vendors and service providers involved in GMP-regulated CSV and automation projects,


• Collaborating with QA, Engineering, Production, and IT teams to ensure sustainable CSV compliance,


• Defining investment, improvement, and revision needs for current and future GMP-CSV compliance and industrial automation requirements,


• Ensuring all validation activities are performed in accordance with applicable GMP regulations, internal procedures, and global data integrity expectations.

Qualifications

• Graduated from Computer Engineering, Software Engineering, or Automation Engineering departments of universities,


• Strong knowledge of computerized systems and industrial automation processes,


• Minimum 3 years of experience in plant CSV activities and 21 CFR Part 11 compliance projects within manufacturing environments,


• Strong knowledge of GAMP5, EU GMP Annex 11 and Annex 15 guidelines, PLC and HMI systems, and backup processes,


• Experienced in troubleshooting, equipment commissioning, system implementation, and retrospective validation activities,


• Preferably experienced in the pharmaceutical industry (sterile manufacturing),


• Proficient in Microsoft Office applications,


• Excellent written and spoken English skills.