Computer Systems Validation Analyst

SMCI is seeking a Computer Systems Validation Analyst to assist company operations teams with all aspects of the computer validation process which includes but not limited to:

• Advising clients on how to meet compliance requirements using a risk-based approach
• Develop validation documentation and standard operating procedures for various GxP applications.
• Develop test protocols that thoroughly test business requirements.
• Provide test execution oversight and assist with deviation recommendations as required.
• Work with client to develop validation plan to ensure that, at the end of the project, the system meets GxP requirements
• Work with client business functions and subject matter experts to develop User Requirements Specification, Functional Requirements Specification, and/or Design Specifications as required
• Development of test / validation scripts based on software design and configuration.
• Develop IQ/OQ scripts as required.

• A minimum of 3 to 5 years in pharmaceutical industry, focusing on Computer Systems Validations
• Experience with large corporations (5000+ staff)
• Ability to multi-task thru different stages of a project
• Thorough understanding of the principles of GAMP, SDLC methodologies and testing best practice.
• Ability to understand existing and new business processes and requirements to ensure proper implementation and validation of systems.
• Expertise with ALM testing and ALM software (HP)
• Expertise in use - Veeva (all modules - CDocs, QMS, RIM, DocuSign, etc)
• Fluent knowledge of rules and regulations: GAMP 5, 21 CFR Part 11 Compliance and CFR Part 210, 211 Compliance.
• Fluent in Microsoft Office suite Including (Excel, Power Point, Visio, Project), Experience with Smartsheets, Salesforce, Tableau a plus
• Ability to work independently, excellent problem solving and professional written communications skills.

• The estimated pay range for this position is USD $65.00/Hr - USD $75.00/Hr and is an Exempt role.
• Exact compensation and offers of employment are dependent on circumstances of each case and will be determined based on job-related knowledge, skills, experience, licenses or certifications, and location.