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Katalyst Healthcares & Life Sciences

Senior CSV Consultant

Pay: Not specified

Posted: 7 weeks ago

Location: Gresham, OR (Onsite)

Last Updated: 3 weeks ago

Hours: Full-Time

Expires: 10/15/2026

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Job Description

Senior CSV Consultant Katalyst Healthcares & Life Sciences - 4.0 Gresham, OR Job Details Contract 1 day ago Qualifications Project team coordination Project reporting Electrical automation system implementation Feature validation testing Software implementation Team scheduling

FDA 21 CFR

Part 11 Key Performance Indicators System validation Production management systems implementation Leading team collaboration initiatives Regulatory/legal compliance standards in production Supervisory control and data acquisition (SCADA) Biomedical regulatory compliance Managing projects Technical writing quality assurance Commissioning phase involvement Senior level Industrial control system installation Content review Project scheduling Regulatory compliance management Documentation reviews

Full Job Description Roles & Responsibilities:

Implement and validate computerized systems including PCS (DeltaV), Rockwell, MES (Syncade), SCADA, and PLC. Author, review, approve, and execute Computer System Validation (CSV) lifecycle documentation. Manage CSV projects, including team coordination, scheduling, reporting, and KPIs. Perform change assessments for DCS (DeltaV) and MES (Syncade) systems. Support commissioning and qualification of DCS software, particularly DeltaV. Ensure compliance with regulatory standards like 21 CFR Part 11 and Annex 11. Collaborate effectively in both independent and team-oriented work environments.