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.

Employment type
Active

Work arrangement
No