Actalent is currently hiring several Validation Engineers for a great, large comapny in the Hillsboro area! This consultant role has the option to be long term. This role also has access to sign up for benefits and more! Job Description This Validation Engineer will be ensuring the computerized systems used in manufacturing and quality (called GxP systems) are safe, reliable, and meet strict regulatory standards. They will do this by writing and reviewing documentation, checking that systems are properly tested and validated, supporting inspections, and helping teams stay compliant over time. Responsibilities of the role: * Determine validation approaches, and identify deliverables needed or impacted by a project / enhancement / change / retirement for GxP computerized systems supported by IT OT. Systems will fall between Level 1, 2 and 3 of the ISA-95 model. * Be responsible for the review of system documentation according to the Roche CSV SOPs and regulatory guidance. * Develop validation plans/reports, reviews test plans/reports (and other deliverables), and assess, authorize, and notify that the system is ready to go live. * Verify testing plans, activities, deliverables, and records, provide consultancy on test-related deviations and corrective actions according to approved procedures. * Support in deviation investigations to identify root causes and define corrective and/or preventative actions. * Support system audit/inspection preparation and execution as CSV subject matter expert. Complete or orchestrate timely completion of post-audit action items. * Support system maintenance and enhancement activities, ensuring the validated state is kept, and it is audit and inspection ready. * Support system periodic reviews according to company procedures. * Collaborate with local and global stakeholders in defining and completing validation and compliance activities. * Coach IT OT personnel on validation and compliance concepts, policies, and procedures. Skills & Qualifications Needed: * Bachelor's in computer science, engineering, or life sciences * 5+ years in a regulated industry (pharma, biotech, etc.) working on IT/OT systems or software validation * Validation & Compliance Expertise (CSV/CSA) * Strong experience with Computer System Validation (CSV) following GAMP guidelines and FDA regulations. * Knowledge of FDA and EU compliance standards like 21 CFR Part 11, Annex 11, and GxP. * Experience working with Level 2 and 3 systems (like SCADA, MES) under the ISA-95 model. Level 1 (sensors, PLCs) is a bonus. * Document & Testing Review Skills * Ability to write and review validation plans, test protocols, and reports accurately. * Skilled at handling deviations and identifying root causes and corrective actions. Experience Level Intermediate Level Pay and Benefits The pay range for this position is $40.00 - $50.00/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 hybrid position in Hillsboro,OR. Application Deadline This position is anticipated to close on May 21, 2025. 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 [email protected] for other accommodation options.