Validation Engineer (Computer System Validation)

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

We are seeking a Validation Engineer to support validation activities within a GMP biotechnology environment. In this role, you will partner closely with IT/OT system owners to manage the full lifecycle of computer systems, including maintenance, validation, documentation, and testing. This is a 12‑month contract based onsite five days a week in Hillsboro, Oregon, offering the opportunity to contribute to critical system reliability and compliance efforts.

Responsibilities

• Create/update Computer System validation and lifecycle support documentation, as the need arises, for ITOT computer systems (DeltaV, PI, MES, SCADA, LyoPLus, FIT, BAS, WAGIT). Systems will fall between Level 2 and 3 of the ISA-95 model.
• Help perform MILE (annual system maintenance) activities for ITOT Systems. For example, create, update, execute, or review installation protocols, test protocols, etc.
• Own Quality Management System records (CAPA, Planned Events, Deviations) and orchestrate completion of activities needed.
• Perform system periodic reviews; This entails performing data collection from the deviations database on the past 3 year’s worth of planned and unplanned events, review impact on system’s validated state and draft reports.
• Support System Owner squad in the overall procurement, development, integration, modification, operation, maintenance, and retirement of ITOT systems.
• Support validation activities, generation, approval and execution of validation protocols.
• Assist System Owners in system maintenance activities such as Periodic System Audit Trail Review, account audits, etc.
• Creating reports for various systems on demand.
• Work with the System Owners and Business Process Owners for the upgrade/patching and changes to the system to ensure GMP compliance.
• Support on documents management systems (Veeva, Condor).
• Support the team with administrative tasks, such as document formatting, document routing.

Qualifications

• Bachelor of Science or equivalent in computer science, engineering, life sciences, or related field.
• Minimum 5 years experience in Computer systems Validation frameworks (CSV/CSA, GAMP), preferably in the Pharma industry.
• Knowledge of or experience with the following technical areas is preferred: SCADA, OSI-PI, Siemens Desigo, Rockwell Factory Talk Pharmasuite, DeltaV, Manufacturing Execution Systems (MES) Systems administration and EBR recipe authoring, software development.
• Good understanding of the ISA-95 model.
• Experience working with Level 2 and Level 3 systems is required.
• Experience working with Level 1 systems is a plus.
• Knowledge of Food and Drug Administration regulations/guidance (i.e. CFR 21 FDA Part 11, Annex 11, EU GMP Annex 1, GxP practices) and Data Integrity principles.
• Good understanding of system and data integrity risk assessment concepts.
• $156,894-$196,123

Why Choose R&D Partners?

As an employee, you have access to a comprehensive benefits package including:

• Medical insurance – PPO, HMO & HSA
• 401k plan
• Employee Assistance Program
• Long-term disability
• Weekly payroll
• Online timecard approval

R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

R&D Partners is an equal-opportunity employer.