Senior Computer System Validation (CSV) Consultant – GxP Systems

Join our team as a Senior Computer System Validation (CSV) Consultant and play a key role in ensuring compliance, quality, and innovation across global Life Sciences and R&D environments.

We are seeking an experienced professional with a strong background in GxP-regulated systems, validation methodologies, and risk-based compliance practices. This is an excellent opportunity to work on cutting-edge projects involving digital transformation, AI-enabled solutions, and global R&D platforms.

Qualifications

• Bachelor's Degree in Science, Technology, Pharmacy, or a related field.
• 8+ years of overall professional experience.
• Minimum of 5 years of hands-on experience in Computer System Validation (CSV) for GxP-regulated systems.

Key Skills & Experience

Core CSV Expertise

• Strong knowledge of:
• 21 CFR Part 11 and 21 CFR Part 820
• GxP regulations
• GAMP 5
• SOX compliance
• EU Annex 11 and Annex 22
• ISO 9001
• ITIL framework
• Experience with:
• Audit and inspection readiness activities
• Periodic system reviews
• Access roster reviews
• Audit trail reviews
• Deviation and CAPA management
• SOP and policy compliance processes
• Proven experience authoring and reviewing:
• User Requirements Specifications (URS)
• Functional Specifications (FS)
• Validation Plans
• Validation Protocols
• Validation Reports
• Final Summary Reports
• High-level understanding of Veeva Vault Suite applications.
• Experience with risk-based testing methodologies aligned with CSA (Computer Software Assurance) principles.

Research & Development (R&D)

High-level understanding of:

• Biostatistics
• Clinical Research
• Drug Discovery
• Medical Affairs
• Pharmacovigilance
• Regulatory Affairs
• RPA GxP Bots
• AI-enabled GxP solutions in R&D environments

What You Can Expect From Us

• Continuous professional development aligned with your career goals.
• Opportunities for international experience.
• A collaborative, diverse, and innovative work environment.
• Exposure to global projects and cutting-edge technologies.
• Strong focus on career growth, learning, and professional advancement.

Benefits

✅ Health Insurance

✅ Dental Plan

✅ Life Insurance

✅ Transportation Allowance

✅ Meal/Food Allowance

✅ Childcare Assistance

✅ TotalPass

✅ 24/7 Employee Assistance Program (psychological, legal, and financial support)

✅ Certification Reimbursement

✅ Learning Platform with free training and courses

✅ Employee Referral Bonus Program

✅ Recognition Program

✅ Mentorship and Career Development Platform