Validation Specialist

JC Automation Corp•Añasco, PR

11h

About The Position

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.

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.

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.