Computer System Validation Engineer

ALTEN Technology USA • Irvine, CA

40d • Onsite

About The Position

We’re ALTEN Technology USA, an engineering company helping clients bring groundbreaking ideas to life—from advancing space exploration and life-saving medical devices to building autonomous electric vehicles. With 3,000+ experts across North America, we partner with leading companies in aerospace, medical devices, robotics, automotive, commercial vehicles, EVs, rail, and more. As part of the global ALTEN Group—57,000+ engineers in 30 countries—we deliver across the entire product development cycle, from consulting to full project outsourcing. When you join ALTEN Technology USA, you’ll collaborate on some of the world’s toughest engineering challenges, supported by mentorship, career growth opportunities, and comprehensive benefits. We take pride in fostering a culture where employees feel valued, supported, and inspired to grow. Position Summary The Computer System Validation (CSV) Engineer II will ensure compliance of computerized systems within a pharmaceutical manufacturing environment. This role focuses on the development, execution, and closure of Installation, Operational, and Qualification (IOQ) protocols for critical systems, including SCADA and Manufacturing Execution Systems (MES). The engineer will work in a cleanroom environment alongside manufacturing equipment to support system qualification activities in accordance with regulatory requirements (FDA, EU GMP, GAMP 5).

Requirements

• Bachelor’s degree in Engineering, Computer Science, or related field.
• 2–4 years of experience in Computer System Validation within a pharmaceutical or regulated industry.
• Hands-on experience with Manufacturing Execution Systems (MES) and iFIX SCADA system qualification.
• Strong understanding of GAMP 5, FDA, and EU GMP guidelines.
• Familiarity with cleanroom operations and manufacturing equipment integration.
• Excellent technical writing and documentation skills.
• Ability to work independently and manage multiple validation projects simultaneously.

Nice To Haves

• Knowledge of automation systems and PLCs.
• Experience with electronic batch records and data integrity principles.
• Strong problem-solving and analytical skills.

Responsibilities

• Develop and author IOQ protocols for computerized systems, ensuring alignment with user requirements and regulatory standards.
• Execute IOQ protocols in a cleanroom environment, coordinating with cross-functional teams (Engineering, QA, Manufacturing).
• Perform data collection, deviation management, and ensure timely resolution of discrepancies during qualification activities.
• Generate and finalize IOQ reports, ensuring complete documentation and compliance with internal SOPs and industry guidelines.
• Support the qualification of iFIX SCADA system and related MES components for manufacturing operations.
• Collaborate with IT and Automation teams to ensure system configurations meet validation requirements.
• Maintain validation documentation in compliance with FDA 21 CFR Part 11 and other applicable regulations.
• Participate in risk assessments and impact analyses for system changes.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees