Validation Engineer
Company: ALTEN Technology USA
Location: Irvine
Posted on: February 14, 2026
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Job Description:
Job Description Job Description 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. About the Role The
Validation Engineer II is responsible for planning, executing, and
closing Installation and Operational Qualification (IOQ) activities
for critical facility and utility systems within a pharmaceutical
manufacturing environment. This includes system-level qualification
of cleanrooms, utilities, and integrated manufacturing systems to
ensure compliance with regulatory standards and internal quality
requirements. 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. Qualifications & Requirements
Education: Bachelor's degree in Engineering, Life Sciences, or
related field. Experience: 3–5 years of validation experience in
pharmaceutical or biotech manufacturing. Hands-on experience with
system-level qualification of critical utilities and cleanroom
environments. Technical Skills: Strong understanding of GMP, FDA,
and ICH guidelines. Proficiency in writing and executing IOQ
protocols and reports. Other Requirements: Ability to work in
cleanroom environments and adhere to gowning procedures. Excellent
documentation and communication skills. Strong analytical and
problem-solving abilities. Preferred Qualifications Experience with
integrated manufacturing systems and risk-based validation
approaches. Familiarity with computerized systems validation and
data integrity principles. Salary Range $95,000 - 110,000 The
actual salary offered is dependent on various factors including,
but not limited to, location, the candidate's combination of
job-related knowledge, qualifications, skills, education, training,
and experience ALTEN Technology is an Equal Opportunity Employer.
Our Policy is to extend opportunities to qualified applicants and
employees on an equal basis regardless of an individual's age,
race, color, sex, religion, national origin, disability, sexual
orientation, gender identity/expression or veteran status. Please
beware of job seeker scams and see this important notice on our
careers page for more information about our recruiting process.
Compliance Notice: Alten USA is a federal contractor subject to the
requirements of the Vietnam Era Veterans' Readjustment Assistance
Act (VEVRAA) and Executive Order 11246. We are an Equal Opportunity
Employer and consider all qualified applicants without regard to
race, color, religion, sex, sexual orientation, gender identity,
national origin, disability, or veteran status. 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.
Keywords: ALTEN Technology USA, Carlsbad , Validation Engineer, Science, Research & Development , Irvine, California
