CSV Application Engineer

About the role

The CSV Application Engineer will lead remediation and compliance activities for computerized systems used in sterile manufacturing. This role ensures that all validation work aligns with GMP, CSV and data integrity standards.

Key responsibilities

• Plan and implement corrective, preventive and improvement actions to meet GMP and CSV requirements.
• Prepare, review and execute CSV documentation such as URS, FS/DS, risk assessments, traceability matrices, IQ/OQ/PQ protocols and validation reports.
• Perform retrospective validation, gap assessments and remediation for existing computerized systems.
• Support lifecycle management including periodic review, change control, deviation handling, CAPA follow‑up, backup verification and audit‑trail review.
• Apply risk‑based decision making throughout validation and compliance activities.
• Provide technical support during customer and regulatory inspections.
• Coordinate with third‑party vendors and service providers on GMP‑regulated CSV and automation projects.
• Collaborate with QA, Engineering, Production and IT to sustain CSV compliance.

Required profile

• Degree in Computer Engineering, Software Engineering or Automation Engineering.
• Minimum three years of experience in plant CSV activities and 21 CFR Part 11 compliance projects.
• Strong knowledge of GAMP5, EU GMP Annex 11 and Annex 15 guidelines.
• Experience in the pharmaceutical sterile manufacturing environment is preferred.

Required skills

• GAMP5
• EU GMP Annex 11
• EU GMP Annex 15
• PLC and HMI systems
• Backup processes
• Microsoft Office
• 21 CFR Part 11 compliance
• CSV validation