Computer Systems Validation (CSV) Sr. Specialist

Arcera is a global life sciences company headquartered in Abu Dhabi, United Arab Emirates. Our purpose is to enable longer and healthier lives while creating sustainable growth. We develop, manufacture, and commercialize a broad range of high-quality innovative and proven medicines in key international markets. With an operational footprint spanning over 90 countries across four continents, and manufacturing sites in eight countries, we offer more than 2,000 medicines across various therapeutic areas worldwide.

The Computer Systems Validation (CSV) Sr. Specialist ensures that all manufacturing machines, equipment, laboratory instruments, and site utilities comply with GxP regulations and 21 CFR Part 11 requirements. This role focuses on preventing data manipulation by establishing rigorous technical controls across the entire site lifecycle.

Key Responsibilities 

Part 11 Technical Controls

• User Access: Enforce unique user IDs and restrict administrative privileges to non-production personnel.
• Audit Trails: Verify that automated audit trails capture the "who, what, when, and why" of all data modifications.
• Data Backup: Implement and test automated, secure backup and archival processes to prevent data loss.
• Security Levels: Map out and restrict system access based strictly on defined operational roles.

Qualification & CSV Risk Assessment for

• Equipment Oversight: production machines and instrument.
• Instrument Control: oversight analytical laboratory instruments compliance with QC compliance responsible from CSV point of view.
• Utility compliance: Review computerized control systems for site utilities (e.g., Purified Water, HVAC, BMS, CA, etc.).
• Risk Assessments: Execute Data Integrity Risk Assessments (DIRA) to identify vulnerabilities to data manipulation for all site GXP related systems &/ premises.
• Alarm Review: Evaluate alarm configurations and audit trail records to identify unauthorized process overrides.

Compliance & Data Integrity

• Data Anti-Manipulation: Design system configurations that eliminate the ability to delete or overwrite raw data.
• Audit Defense: oversight the site's CSV and Part 11 compliance posture during regulatory agency inspections.
• CAPA Management: Investigate computer system deviations and implement corrective actions for compliance gaps.

Qualifications & Experience 

• Automation: Deep understanding of PLCs, SCADA systems, Distributed Control Systems (DCS), and Historians.
• Lab Systems: Technical knowledge of standalone software for laboratory instruments and chromatography systems.

• Bachelor’s degree in pharmaceutical sciences with previous CSV experience is a must.
• 4-7 years of CSV experience specifically within a pharmaceutical manufacturing facility.
• Comprehensive expertise in GAMP5, 21 CFR Part 11, EU Annex 11, and PIC/S guidelines.
• Excellent communication in English language is a must.

This is the opportunity to join a very dynamic organization, where decisions are taken fast and where you can actively participate in shaping our future. If this sounds exciting, we would love to hear more about you!