Job Title: Computer Validation Specialist

　　Location: Bothell, WA

　　Compensation: $60.00-$67.55

　　Type: Long Term contract 12 month with the possibility of extending

　　Overview

　　Leading Pharmaceutical Company located in Bothell, WA is hiring a Computer Validation Specialist with 3 to 5 years of industry experience. Our clients work every day to transform patients’ lives through science. Each day, our clients employees around the world work together for patients – they are at the center of everything they do. If you want to be a part of this groundbreaking work, please apply!

　　Responsibilities

　　Lead site-specific CSV activities for computer system integration projects (i.e., ERP, MES etc.), coordinating with the global/site specific system technology and validation teams.

　　Strong knowledge of GAMP / risk-based approaches to validation (i.e., Computer Software Assurance [CSA]), and good understanding of electronic record / signature management practices.

　　Lead routine CSV lifecycle activities (system periodic validation lifecycle and audit trail / user access reviews/Periodic review), coordinating with business owners, technical system owners and Quality in accordance with company procedures and regulatory requirements.

　　Author, review and/or approve applicable CSV documentation.

　　Perform or oversee test script execution efforts, including defect management.

　　Ensure validation test strategies align with internal procedures and requirements for intended use.

　　Assist Business Owners and Technical Owners to develop requirements and specifications for computerized systems used in GxP operations.

　　Experience in following CSV methodology for system evaluations, changes, and implementations.

　　Ability to work independently.

　　Other related duties as assigned.

　　Requirements

　　Education:

　　Master’s Degree with 2+ years of direct experience in Validation in a pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments, OR; Bachelor’s Degree with 4+ years of direct experience in Validation in a pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments.

　　Preferred Qualifications:

　　Experience in a biotechnology or pharmaceutical cGMP manufacturing environment preferred.

　　Experience with development of CSV documentation (Validation Plans, Requirements, Specifications, Assessments, Test Scripts [IQ / OQ / PQ], Reports, Trace Matrices, SOPs, etc.).

　　3-5+ years’ experience in performing periodic review of computerized systems.

　　Experience with Valgenesis/Veeva Vault CR/PR/CAPA systems.

　　Strong critical thinking and problem-solving skills

　　Strong interpersonal skills to work with teams in different functions and organizations.

　　GXP Equipment Validation

　　Benefits

　　System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

　　System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

　　System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.