Computer System 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, ManufacturingIndustries

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

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

Skills

CSV

IOQ

SCADA

iFIX

MES

GAMP 5

FDA

EU GMP

cleanroom

deviation management

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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