CSV Validation Engineer — GMP Automation & Compliance

Acino International AG; Turkey; On-site; TRY 2,131,060 - 3,196,590; Full time

Job summary

Acino International AG is seeking a CSV Specialist in Turkey. The role involves managing CSV remediation and compliance activities in sterile manufacturing, executing documentation, and collaborating with various teams. Candidates should have a degree in Computer Engineering and at least 3 years of plant CSV experience, with strong knowledge of GAMP5 and 21 CFR Part 11 guidelines. Excellent communication skills in English are essential.

Qualifications

• Minimum 3 years of experience in plant CSV activities and 21 CFR Part 11 compliance projects.
• Strong knowledge of PLC and HMI systems.
• Proficient in written and spoken English.

Responsibilities

• Responsible for CSV remediation and compliance activities.
• Planning and implementing corrective actions for compliance.
• Coordinating with QA, Engineering, Production, and IT teams.

Skills

Knowledge of computerized systems

Experience in plant CSV activities

Knowledge of GAMP5

Troubleshooting skills

Education

Degree in Computer Engineering, Software Engineering, or Automation Engineering

Tools

Microsoft Office

Job description

Acino International AG is seeking a CSV Specialist in Turkey. The role involves managing CSV remediation and compliance activities in sterile manufacturing, executing documentation, and collaborating with various teams. Candidates should have a degree in Computer Engineering and at least 3 years of plant CSV experience, with strong knowledge of GAMP5 and 21 CFR Part 11 guidelines. Excellent communication skills in English are essential.