Validation Specialist

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 & CQV Specialist is responsible for supporting Computer System Validation (CSV), Commissioning, and Qualification (CQV) activities within a cGMP-regulated environment.

This role ensures that systems and equipment are validated, compliant, and operate according to regulatory requirements, data integrity standards, and internal quality procedures.Key Responsibilities:Participate in project team meetings, providing input on timelines, deliverables, risks, and task status.Execute CSV and CQV activities including system validation, commissioning, and equipment qualification.Develop and maintain validation documentation such as Validation Plans, Risk Assessments, Traceability Matrices, Test Protocols (IQ/OQ/PQ), and Summary Reports.Support development and revision of SOPs, including administrative and operational procedures.Perform data integrity assessments and support remediation activities.Support installation and operational verification of system interfaces and external connectivity.Lead and support change control activities, including requirement gathering, documentation, and implementation.Generate and present change controls to Change Control Review Boards.Support source code review, system inventory management, and configuration documentation.Ensure compliance with cGMP regulations, data integrity standards, and internal quality systems.Perform general automation and system administration tasks as required.Maintain compliance with training and Individual Learning Plan requirements.Requirements:Bachelor’s degree in Engineering, Life Sciences, Computer Science, or related field.Experience in Computer System Validation (CSV) and/or Commissioning & Qualification (CQV) in regulated environments.Strong knowledge of validation lifecycle documentation (URS, DS, IQ/OQ/PQ, TMX, etc.).Familiarity with change control processes and quality systems.Knowledge of data integrity principles and regulatory expectations (FDA, cGMP).Strong organizational, documentation, and communication skills.Ability to manage multiple tasks and work in cross-functional teams.Must be authorized to work in the United States without sponsorship.Location:Puerto Rico