CSV Application Engineer
About this role
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.
Frequently Asked Questions
Is the salary disclosed for the CSV Application Engineer position at acino?
The salary for this CSV Application Engineer role at acino is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the CSV Application Engineer position at acino located?
This CSV Application Engineer role at acino is based in Turkey, Turkey. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the CSV Application Engineer role at acino full-time or part-time?
This is listed as a Active position. It is posted as a CSV Application Engineer role at acino.
How do I apply for the CSV Application Engineer position at acino?
Click the "Apply Now" button on this page. You will be redirected to acino's official application portal hosted on bamboohr where you can submit your application directly.
When was the CSV Application Engineer job at acino posted?
This CSV Application Engineer position at acino was posted on May 12, 2026. Apply as soon as possible — early applications are often reviewed first.
CSV Application Engineer
acino
You'll be redirected to acino's official application page on bamboohr.