Computer System Validation Contractor

Location: Hillsboro, OR – Onsite Position
Type: 12-Month Contract (possibility of extension)

About the Opportunity

Are you passionate about Information Technology (IT) and Automation Technology (OT) and eager to make a meaningful impact? Do you want to help shape digital manufacturing architecture and drive future competitiveness in the market?

This role offers the chance to work in a highly automated pharmaceutical drug substance facility, playing a key part in supporting integrated computer control systems that manage plant operations and manufacturing data. You will be actively involved in daily operations of Manufacturing ITOT systems and infrastructure, while contributing to ongoing transformation initiatives focused on digitalization, standardization, and the adoption of new technologies.

Key Responsibilities

• Review system documentation in line with Computer System Validation (CSV) standards and regulatory guidance.

• Develop and update validation deliverables, including validation plans/reports, test plans/reports, and procedures, in collaboration with system owners.

• Apply ALCOA principles to validation deliverables and quality management records.

• Support deviation investigations by identifying root causes and defining corrective/preventive actions.

• Serve as CSV subject matter expert during audits/inspections, including preparation, execution, and post-audit follow-up.

• Ensure validated systems remain in a compliant state and are audit/inspection ready.

• Perform periodic system reviews in accordance with company procedures.

• Collaborate with local and global stakeholders to define and complete validation and compliance activities.

Education & Experience

• Bachelor's degree in Computer Science, Engineering, Life Sciences, or related field.

• 6 years of experience in IT, OT, Software Technical Writing, Quality Systems, or Validation (CSV/CSA, GAMP), preferably in a regulated industry.

• Solid understanding of the ISA-95 model, with required experience in Level 2 and Level 3 systems; Level 1 experience is a plus.

• Strong knowledge of FDA regulations/guidance (e.g., 21 CFR Part 11, Annex 11, EU GMP Annex 1, GxP practices) and Data Integrity principles.

• Understanding of system and data risk assessment concepts.

Competencies & Behaviors

• Takes responsibility, drives results, and achieves expected outcomes.

• Effective communicator with strong verbal and written communication skills.

• Collaborative team player, capable of working in cross-functional and agile environments.

• Builds trustful and effective relationships.

• Innovative thinker who translates ideas into actionable plans.

• Comfortable working with stakeholders across diverse technical domains and cultures.

Technical Skills (Preferred)

• Experience with: system administration, software development, networking, server administration, MES systems administration/recipe authoring, industrial data, and manufacturing controls systems.

• Familiarity with IT Service Management, Quality, and Document Management systems (e.g., Veeva, ALM, Valgenesis, ServiceNow).

• Awareness of key trends such as Smart Manufacturing, Industrial IoT, Digital Plant Maturity, Cybersecurity, Pharma 4.0, and technology/data standardization.

Why Nesco Resource?

Nesco Resource offers a comprehensive benefits package for associates, including:

• MEC (Minimum Essential Coverage) plan (Medical, Dental, Vision)

• 401(k) retirement savings plan

• Employee Assistance Program (EAP) services
  

We are proud to provide equal employment opportunities to all employees and applicants. We prohibit discrimination and harassment of any kind based on race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by law.