Computer System Validation Specialist - Onsite jobs in United States
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Aldevron · 18 hours ago

Computer System Validation Specialist - Onsite

positionFargo, ND
timeFull-time
remoteOnsite
seniorityEntry, Mid Level
date2+ years exp

Aldevron, a Danaher operating company, is seeking a Computer System Validation Specialist to contribute to continuous improvement and operational excellence within life sciences, diagnostics, and biotechnology. The role involves ensuring computerized systems comply with Good Manufacturing Practices and collaborating with stakeholders to maintain quality and regulatory compliance.

BiotechnologyCommercialIndustrialManufacturing
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H1B Sponsor Likelynote

Responsibilities

Contribute to risk assessments and management processes; support QMS functions including Deviations, Change Control, and CAPA
Author, review, and/or contribute to User Requirements, Configuration, and Functional Specifications; develop and execute Qualification protocols and other testing activities
Perform lifecycle tasks such as periodic reviews, change management, and system decommissioning

Qualification

ValidationGxP quality systemsManufacturing PracticesRisk managementTechnical writingProfessional communicationComputer hardware/softwareScience-based critical thinkingBiomanufacturingEnterprise software platformsComputerized analytical instruments

Required

Associate's degree in engineering, biology, computer science, mathematics, or related discipline and 2+ years in a technical role (e.g., Engineering, IT, lab work); or equivalent combination of education and experience
Experience in Validation, GxP quality systems, software quality, biomanufacturing, or related fields (may substitute for degree); basic understanding of GMP regulatory requirements
Professional communication and technical writing; proficiency with computer hardware/software for business functions

Preferred

Familiarity (operation, commissioning, and/or design) with any of: computerized chemical/biological manufacturing systems, enterprise software platforms (ERP, eQMS, LIMS), computerized analytical instruments
Demonstrated proficiency in science-based critical thinking and risk management

Benefits

Health care program
Paid time off

Company

Aldevron

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Aldevron is a biological development and manufacturing organization specializing in cell and genetic engineering.
dateFounded in 1998
location
Fargo, North Dakota, USA
people-size1001-5000 employees
web-link
http://www.aldevron.com/

H1B Sponsorship

Aldevron 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 (10)
2024 (8)
2023 (10)
2022 (6)

Funding

Current Stage
Late Stage
Total Funding
unknown
Key Investors
TA Associates
2021-06-17Acquired
2019-01-01Private Equity
2017-01-24Private Equity

Leadership Team

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Kevin Ballinger
Chief Executive Officer
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Nathan Spangler
Senior Director, IVT mRNA Services Platform
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