Validation Engineer at ALTEN Technology

Irvine, California, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, Aerospace, Medical Devices, AutomotiveIndustries

Requirements

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

Responsibilities

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
Author detailed qualification protocols and ensure alignment with regulatory and company standards
Perform qualification activities in cleanroom environments, document results, and manage deviations and corrective actions
Compile and finalize qualification reports, ensuring traceability and compliance with GMP and validation standards
Work closely with engineering, operations, and quality teams to maintain validated state of systems
Ensure adherence to FDA, EMA, and ICH guidelines for system-level validation
Identify opportunities for improving qualification processes and system reliability

Skills

IOQ

Validation Protocols

GMP

Cleanroom Qualification

WFI

Clean Steam

Compressed Air

Nitrogen Systems

Deviation Management

Corrective Actions

Pharmaceutical Manufacturing

Regulatory Compliance

ALTEN Technology

Engineering services for technology and product development

About ALTEN Technology

ALTEN Technology provides engineering services focused on technology and product development across various industries, including aerospace, medical devices, and automotive technology. The company helps clients create advanced products like space exploration tools, medical devices, and autonomous electric vehicles. Their services include agile software development and custom software solutions, which are tailored to meet the specific needs of each client. This collaborative approach aims to reduce risks and ensure successful project outcomes. Unlike many competitors, ALTEN Technology emphasizes a flexible and client-centered model, allowing them to adapt to the unique demands of each project. The goal of ALTEN Technology is to support clients in developing innovative products while securing long-term partnerships through their specialized engineering services.

7830 Thorndike Rd, Greensboro, NC 27409, USAHeadquarters

1988Year Founded

MERGERCompany Stage

Automotive & Transportation, Enterprise Software, Aerospace, HealthcareIndustries

501-1,000Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

401(k) Retirement Plan

401(k) Company Match

Paid Vacation

Paid Parental Leave

Risks

Emerging firms using AI pose competitive threats with cost-effective solutions.

Talent shortages in aerospace and medical fields may delay project timelines.

Merger integration challenges with Syncroness could disrupt service delivery temporarily.

Differentiation

ALTEN Technology offers comprehensive engineering services across aerospace, medical, and automotive sectors.

The merger with Syncroness expands ALTEN's service offerings and strengthens its market position.

ALTEN's collaborative approach tailors solutions to specific client needs, reducing project risks.

Upsides

Growing demand for digital twin technology boosts ALTEN's aerospace and automotive projects.

Edge computing enhances ALTEN's real-time applications in autonomous vehicles and medical devices.

AI integration improves predictive maintenance, reducing downtime in aerospace and automotive sectors.

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