ALTEN · 1 month ago
Computer System Validation Engineer
Irvine, CA
Full-time
Onsite
Entry, Mid Level
$95K/yr - $110K/yr
2+ years expALTEN Technology USA is an engineering company that helps clients bring groundbreaking ideas to life. The Computer System Validation Engineer II will ensure compliance of computerized systems within a pharmaceutical manufacturing environment, focusing on the development, execution, and closure of Installation, Operational, and Qualification (IOQ) protocols for critical systems.
Information Technology
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
Qualification
Required
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
Preferred
Knowledge of automation systems and PLCs
Experience with electronic batch records and data integrity principles
Strong problem-solving and analytical skills
Benefits
Comprehensive benefits
Drug Screening Requirement: As a federal contractor, Alten USA maintains a drug-free workplace. All candidates selected for employment will be required to successfully complete a pre-employment drug screening as a condition of hire.
Company
ALTEN
Alten is high-technology consulting and engineering group. The group's services are supplied to technical departments.
10001+ employees
H1B Sponsorship
ALTEN has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
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Trends of Total Sponsorships
2025 (101)
2024 (89)
2023 (76)
2022 (64)
2021 (80)
2020 (69)
Funding
Current Stage
Public CompanyTotal Funding
unknown1999-04-01IPO
Leadership Team
Lesly Mouchnino
UX Designer
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