GMP CSV Validation Engineer – IT/OT Systems (12‑Month)

R&D Partners; Hillsboro (OR); On-site; USD 156,894 - 196,123; Full time

Benefits offered by this job

Medical insurance – PPO, HMO & HSA

401k plan

Employee Assistance Program

Long-term disability

Weekly payroll

Job summary

A leading biotechnology firm is seeking a Validation Engineer for a 12-month contract in Hillsboro, Oregon. The role involves supporting validation activities in a GMP environment, managing computer systems lifecycle, and ensuring compliance with FDA regulations. Ideal candidates will have 5+ years of experience in computer systems validation and knowledge of relevant technical areas. The company offers a comprehensive benefits package, including medical insurance, 401k plans, and weekly payroll.

Qualifications

• Minimum 5 years experience in Computer systems Validation frameworks.
• Experience working with Level 2 and Level 3 systems is required.
• Knowledge of FDA regulations and guidance is essential.

Responsibilities

• Create/update validation documentation for ITOT computer systems.
• Perform annual maintenance activities for ITOT Systems.
• Own Quality Management System records and complete necessary activities.

Skills

Computer systems Validation frameworks (CSV/CSA, GAMP)

SCADA

Manufacturing Execution Systems (MES)

Data Integrity principles

ISA-95 model

Education

Bachelor of Science or equivalent in computer science, engineering, life sciences, or related field

Tools

Veeva

Condor

DeltaV

OSI-PI

Rockwell Factory Talk Pharmasuite

Job description

A leading biotechnology firm is seeking a Validation Engineer for a 12-month contract in Hillsboro, Oregon. The role involves supporting validation activities in a GMP environment, managing computer systems lifecycle, and ensuring compliance with FDA regulations. Ideal candidates will have 5+ years of experience in computer systems validation and knowledge of relevant technical areas. The company offers a comprehensive benefits package, including medical insurance, 401k plans, and weekly payroll.