Validation Leader: CSV, Process & Compliance

Alcott Global; United States; On-site; USD 140,000 - 210,000; Full time

Job summary

Alcott Global is seeking an Associate Director - Computer System Validation in El Paso, TX. The role oversees CSV, Cleaning, Process, and Facility Validation, ensuring compliance with FDA regulations, EU GMP, and global standards while leading the Validation Master Plan and lifecycle activities.

The ideal candidate will bring 10+ years in validation, 5+ years in leadership, and a proven track record in NPI, technology transfers, and risk-based validation with strong regulatory inspection

Qualifications

• 10+ years in Validation, Pharmaceutical Manufacturing, Biotech or Medical Device Manufacturing.
• 5+ years leading validation teams or site-level validation functions.
• Strong knowledge of FDA/EU GMP/ISO/ICH guidelines and data integrity expectations.

Responsibilities

• Lead end-to-end Validation Program and Validation Master Plan in line with lifecycle validation principles.
• Act as site SME for CSV, Cleaning, Process, Facility Validation, and Preventive Maintenance programs.
• Ensure CSV compliance with 21 CFR Part 11, Annex 11 and ALCOA+ data integrity across systems.
• Establish robust Cleaning Validation strategies and CPV throughout product lifecycle.
• Oversee NPI and Technology Transfer validation activities and Stage 1–3 processes.
• Manage Cleanroom, Facility, Utility, and Environmental Qualification activities (HVAC, ISO 14644).
• Drive Quality Systems, Regulatory Compliance, and risk management; lead inspections and audits.
• Develop and mentor the Validation organization and foster a culture of excellence.

Skills

Validation leadership

Regulatory compliance

Cross-functional leadership

FDA/EMA experience

Data integrity (ALCOA+)

NPI/Technology Transfer

Job description

Alcott Global is seeking an Associate Director - Computer System Validation in El Paso, TX. The role oversees CSV, Cleaning, Process, and Facility Validation, ensuring compliance with FDA regulations, EU GMP, and global standards while leading the Validation Master Plan and lifecycle activities.

The ideal candidate will bring 10+ years in validation, 5+ years in leadership, and a proven track record in NPI, technology transfers, and risk-based validation with strong regulatory inspection