Computer System Validation Specialist - Onsite
About The Position
Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Aldevron, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. At Aldevron, we deliver world-class CDMO services that accelerate the development of groundbreaking therapies. Our mission is to be the engine of innovation for genomic medicine pioneers. As a member of our team, you’ll help bring life-changing innovations to life—impacting millions around the world. We bring together deep scientific expertise, an unwavering commitment to quality, and a collaborative spirit to drive progress. Whether you're launching your career or bringing years of experience, we value the unique perspective you bring. Join us and become part of a mission-driven team advancing science and unlocking human potential—one discovery at a time. Learn about the Danaher Business System which makes everything possible. The CSV Specialist is responsible for taking an active role in Aldevron’s realization of continuous improvement and operational excellence through digital technology, while maintaining quality and a state of regulatory compliance. CSV Specialists will use science-based critical thinking to ensure new and existing computerized systems are implemented and operated in compliance with Good Manufacturing Practices. CSV Specialists will regularly collaborate with all stakeholders in a system/project and will be responsible for generating documented evidence which provides assurance that our computerized systems function reliably and are fit for their intended use. This position reports to the Computer Systems Validation Manager and is part of the IT Team located in Fargo, ND and will be an on-site role.
Requirements
- 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
Nice To Haves
- 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
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.
Benefits
- Aldevron, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Associate degree
Number of Employees
5,001-10,000 employees
