CSV Engineer
Job in
Hillsboro, Washington County, Oregon, 97104, USA
Listed on 2026-07-26
Listing for:
Katalyst HealthCares & Life Sciences
Full Time
position Listed on 2026-07-26
Job specializations:
-
IT/Tech
Systems Engineer, Information Security & Data Protection, Cybersecurity
Job Description & How to Apply Below
Job Description
We are seeking an experienced Computer Systems Validation (CSV) Engineer with strong communication skills and a true consultant mindset. The ideal candidate will have solid experience in pharma validation environments and hands-on exposure to manufacturing and automation systems.
Requirements- Bachelor's degree in computer science, Engineering, Life Sciences, or related field.
- + years of experience in CSV/CSA frameworks (GAMP) within the Pharma industry.
- Hands-on experience with SCADA, OSI-PI, , Rockwell Factory Talk Pharma Suite, DeltaV, and MES.
- Experience with system administration and E recipe authoring preferred.
- Strong understanding of ISA- model (Level & Level required; Level is a plus).
- Knowledge of FDA regulations (CFR Part), Annex, EU GMP Annex, GxP practices, and Data Integrity principles.
- Experience performing system and data integrity risk assessments.
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