Computer System Validation Engineer

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