Computer System Validation Engineer jobs in United States
cer-icon
Apply on Employer Site
company-logo

ALTEN Technology USA · 2 weeks ago

Computer System Validation Engineer

positionIrvine, CA
timeFull-time
remoteOnsite
seniorityEntry, Mid Level
money$95K/yr - $110K/yr
date2+ years exp

ALTEN Technology USA is an engineering company that supports clients in various industries including aerospace and medical devices. The Computer System Validation Engineer II will ensure compliance of computerized systems in a pharmaceutical manufacturing environment, focusing on the development and execution of qualification protocols.

ConsultingInformation Technology
check
H1B Sponsor Likelynote

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

Computer System ValidationManufacturing Execution SystemsIFIX SCADA systemGAMP 5FDA guidelinesEU GMP guidelinesTechnical writingAnalytical skillsCleanroom operationsData integrity principlesAutomation systemsPLCsProblem-solving skills

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

Company

ALTEN Technology USA

twittertwittertwitter
Glassdoor3.4
company-logo
ALTEN Technology USA is an engineering consulting company. It is a sub-organization of Alten.
dateFounded in 1988
location
Greensboro, North Carolina, USA
people-size501-1000 employees
web-link
https://altenusa.com/

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 Stage

Leadership Team

leader-logo
Mark Henault
Chief Technology Officer at Alten Technology
linkedin
leader-logo
Mike Walraven
Chief Administrative Officer
linkedin

Recent News

PRLog
ATEN Technology Renovates the Desktop for the Hybrid Work Challenge with New KVM Switch
2022-09-29
Company data provided by crunchbase