CSV Application Engineer

About the Position

We are seeking a CSV Application Engineer with strong knowledge of computerized systems and industrial automation processes to ensure compliance with GMP and CSV requirements in sterile manufacturing operations.

Responsibilities

• 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.

Requirements

• 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.

We Offer

• Opportunity to work in a dynamic and growing company.
• Competitive salary and benefits package.
• Professional development and career growth opportunities.

About the Company

Acino is a leading company in the pharmaceutical industry, dedicated to providing high-quality products and services. We are committed to excellence and innovation in our field.

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Location: Turkey

Employment Type: Active