ALTEN Technology USA · 5 hours ago
Validation Engineer
Irvine, CA
Full-time
Onsite
Mid Level
$95K/yr - $110K/yr
3+ years expALTEN Technology USA is an engineering company that assists clients in bringing innovative ideas to fruition across various sectors including aerospace and medical devices. The Validation Engineer II is responsible for planning, executing, and closing Installation and Operational Qualification (IOQ) activities for critical facility and utility systems in a pharmaceutical manufacturing environment, ensuring compliance with regulatory standards and internal quality requirements.
ConsultingInformation Technology
Responsibilities
System-Level Qualification: Develop and execute IOQ protocols for facility and utility systems such as Water for Injection (WFI), clean steam, nitrogen/compressed air gases, and cleanroom environments
Protocol Development: Author detailed qualification protocols and ensure alignment with regulatory and company standards
Execution & Documentation: Perform qualification activities in cleanroom environments, document results, and manage deviations and corrective actions
Report Closure: Compile and finalize qualification reports, ensuring traceability and compliance with GMP and validation standards
Cross-Functional Collaboration: Work closely with engineering, operations, and quality teams to maintain validated state of systems
Compliance & Standards: Ensure adherence to FDA, EMA, and ICH guidelines for system-level validation
Continuous Improvement: Identify opportunities for improving qualification processes and system reliability
Qualification
Required
Bachelor's degree in Engineering, Life Sciences, or related field
3–5 years of validation experience in pharmaceutical or biotech manufacturing
Hands-on experience with system-level qualification of critical utilities and cleanroom environments
Strong understanding of GMP, FDA, and ICH guidelines
Proficiency in writing and executing IOQ protocols and reports
Ability to work in cleanroom environments and adhere to gowning procedures
Excellent documentation and communication skills
Strong analytical and problem-solving abilities
Preferred
Experience with integrated manufacturing systems and risk-based validation approaches
Familiarity with computerized systems validation and data integrity principles
Benefits
Comprehensive benefits
Drug Screening Requirement: As a federal contractor, Alten USA maintains a drug-free workplace.
Company
ALTEN Technology USA
ALTEN Technology USA is an engineering consulting company. It is a sub-organization of Alten.
501-1000 employees
H1B Sponsorship
ALTEN Technology USA 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
Represents job field similar to this job
Trends of Total Sponsorships
2025 (101)
2024 (89)
2023 (76)
2022 (64)
2021 (80)
2020 (69)
Funding
Current Stage
Late StageLeadership Team
Mark Henault
Chief Technology Officer at Alten Technology
Mike Walraven
Chief Administrative Officer
Recent News
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