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CSV Application Engineer

Acino

Turkey, Turkey Posted 30+ days ago
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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.

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