Validation Specialist at Everett

Job Description

Validation Specialist

As a member of the Validation department, participate in all phases of computerized system validation including the planning, writing, editing, assessment of regulatory risk and review of the following validation deliverables; project plans, validation plans, system requirements, test plans, test scripts, traceability matrix, exception reports, and summary reports. The Validation Specialist will participate in the development, revision and maintenance of validation documentation such as the master validation plan, validation SOPs, and quality management systems designed to assist in the organization, planning, execution, monitoring, and reporting of validation activities.

 

Responsibilities 

• Interpret and implement industry best practices, regulatory requirements such as GLP, 21 CFR Part 11 and corporate policy.
• Contribute to the development and maintenance of validation quality management system (e.g. Master Computerized Systems List, a Master Validation Schedule, and Validation Department SOPs).
• Oversees projects, including the scheduling of resources, tasks, and providing project status reports.
• Generate and maintain validation deliverables to support the execution of computerized system validation activities.
• Monitor the execution of test plans, acceptance criteria and test results for computerized system validation activities.
• Monitor and provide assistance for vendor supplied computerized system validation services.
• Maintain inventories, lists, status, and other tracking tools of approved validation documentation, system configuration, change control, etc.
• Ensure adherence to change management procedures for validated systems.
• Conduct technical assessments on change control, system usage SOPs, etc. for validation compliance and impact.
• Respond to internal/external audit findings and contribute to corrective actions as needed.
• Utilize diagramming software to assist in the creation of dataflow and system diagrams.
• Other related duties as assigned to meet departmental and Company objectives.

 

 

Job Requirements

• B.S./M.S. degree, preferably in scientific or technical discipline or equivalent combination of education, related experience and/or certified training.
• 2+ years of computerized system validation experience within the GLP/GMP regulated environment (i.e., 21 CFR Part 11 and 58). Good procedural and technical documentation skills.
• Proficient in the use of MS Office (Word, Excel, Visio, PowerPoint) and project management tools.
• Excellent written & verbal communication skills
• Working knowledge of applied mathematics used in the life sciences industry, advanced algebra, regression analysis, and statistics.
• Continual GLP training and 21 CFR Part 11 and computer hardware, software, networking and security.

 

Company Overview

 

For more than 55 years, SNBL (Shin Nippon Biomedical Laboratories, Ltd) has been a leader in helping biopharmaceutical companies generate high quality data with the exceptional precision needed to rapidly advance new medical therapies and innovations that improve patients’ lives, SNBL has facilities in Japan, the United States, China, and Cambodia. Our international footprint enables us to meet the research needs of clients around the globe. We are committed to providing our customers with fast and precise results across the entire drug development spectrum, from early discovery research to late-stage clinical trials.  The SNBL team is dedicated as a company and as individuals in working with our clients to improve patient care and treatment outcomes. This is a cornerstone in our drive for excellence across all aspects of our business.

Country: USA, State: Washington, City: Everett, Company: SNBL USA.