Job Title: Validation Engineer II - CSV and Compliance SupportJob Description

We are seeking a skilled Validation Engineer II to provide support in CSV and compliance activities. This role involves collaborating with ITOT system owners to maintain, validate, and document computer systems. The position requires expertise in lifecycle support documentation and system maintenance activities, ensuring GMP compliance and quality management.

ResponsibilitiesSupport ITOT System owners with lifecycle tasks related to computer systems, including maintenance, validation, documentation, and testing.Create and update Computer System validation and lifecycle support documentation for various ITOT computer systems such as DeltaV, PI, MES, SCADA, LyoPLus, FIT, BAS, and WAGIT.Perform annual system maintenance activities, including creating, updating, executing, or reviewing installation protocols and test protocols.Own Quality Management System records, such as CAPA, Planned Events, and Deviations, and orchestrate the completion of necessary activities.Conduct system periodic reviews by collecting data on planned and unplanned events from the deviations database and draft reports on system impact.Support System Owner squads in procurement, development, integration, modification, operation, maintenance, and retirement of ITOT systems.Assist in validation activities, including generation, approval, and execution of validation protocols.Help System Owners with system maintenance activities, such as Periodic System Audit Trail Review and account audits.Create reports for various systems upon request.Collaborate with System Owners and Business Process Owners on system upgrades, patching, and changes to ensure GMP compliance.Manage documents in systems like Veeva, Condor, eVal, and Roche.Support the team with administrative tasks, including document formatting and routing.Collaborate with local and global stakeholders to define and complete validation and compliance activities.Attend Quality Huddle Meetings and provide Quality Metrics.Align with global Validation protocols and policies.Essential SkillsBachelor of Science or equivalent in computer science, engineering, life sciences, or related field.Minimum 5 years of experience in Computer Systems Validation frameworks (CSV/CSA GAMP), preferably in the Pharma industry.Knowledge of technical areas such as SCADA, OSI-PI, Siemens Desigo, Rockwell Factory Talk, Pharmasuite, DeltaV, and Manufacturing Execution Systems (MES).Experience in systems administration and EBR recipe authoring software development.Understanding of the ISA-95 model, with experience in Level 2 and Level 3 systems required and Level 1 systems as a plus.Knowledge of FDA regulations/guidance like CFR 21, FDA Part 11, Annex 11 EU GMP Annex 1, GxP practices, and Data Integrity principles.Understanding of system and data integrity risk assessment concepts.Additional Skills & QualificationsExperience with Level 1 systems is a plus.Knowledge of pharmaceutical industry practices.Work Environment

The role involves working with various ITOT computer systems and technologies, including DeltaV, PI, MES, SCADA, LyoPLus, FIT, BAS, and WAGIT, which fall between Level 2 and 3 of the ISA-95 model. The work environment includes collaboration with local and global stakeholders, and participation in Quality Huddle Meetings. The position requires attention to detail in document management and administrative support, with a focus on GMP compliance.

Job Type & Location

This is a Contract position based out of Hillsboro, OR.

Pay and Benefits

The pay range for this position is $75.00 - $82.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Hillsboro,OR.

Application Deadline

This position is anticipated to close on Feb 13, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.