CSV Consultant (MES Experience)

Job DescriptionJob DescriptionAbout Company:JC Automation Corp. (JCA) was founded in 1997 with the mission of filling a gap between technology and regulatory requirements in the life science manufacturing industry. The company offers highly capable resources at an affordable cost to build solutions and execute projects in: Automation, Control Systems Integration, Information Technology, System Integration and Regulatory Compliance.JCA is a HUBZone Certified Small Business Firm, NMSDC Certified Minority Business Enterprise, and Certified Critical Industry Supplier. It’s mission is to add value by delivering quality services & solutions on time all the time by transforming processes & technology into business advantages.Job Summary: The CSV Consultant (MES Experience) is responsible for supporting project execution, system design, and Computer System Validation (CSV) activities for Manufacturing Execution Systems (MES) within a cGMP-regulated environment.

This role ensures that systems are implemented, validated, and maintained in compliance with regulatory requirements and business needs.Key Responsibilities:Project Management:Estimate task duration and resource requirements to support project planning.Prioritize tasks based on business needs, dependencies, and project milestones.Develop and maintain project schedules, tracking timelines, deliverables, and risks.Coordinate activities across internal teams and external partners to ensure timely execution.Analysis & Design:Gather and analyze business and system requirements through interviews, workshops, and process reviews.Translate business needs into functional and technical requirements.Prepare technical documentation and presentations for stakeholders (business, QA, technical teams, and leadership).Support system design discussions and contribute to solution definition aligned with user and regulatory requirements.Computer System Validation (CSV):Develop and execute validation deliverables including Risk Assessments, Validation Protocols, Test Scripts, Deviations, and Summary Reports.Perform and review validation activities in compliance with GxP, 21 CFR Part 11, Annex 11, and internal procedures.Collaborate with Quality Assurance to define and align validation strategies.Ensure all validation documentation meets quality standards and is audit-ready.Requirements:Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related field.Experience in Computer System Validation (CSV) within regulated environments (pharma/biotech preferred).Hands-on experience with Manufacturing Execution Systems (MES).Strong knowledge of regulatory requirements (GxP, 21 CFR Part 11, Annex 11).Experience in requirements gathering, system design, and technical documentation.Strong project coordination and organizational skills.Excellent communication and stakeholder management abilities.Must be authorized to work in the United States without sponsorship.Location:Puerto Rico