Job Description
Company Overview
JC Automation is a global management and technology consulting firm dedicated to delivering innovative solutions across IT, automation, and regulatory compliance. We serve leading organizations, governmental agencies, and private institutions worldwide, providing expert support from system implementation to ongoing management and support.
Job Summary:
The Junior Validation Resource supports validation, maintenance, and change control activities within a cGMP-regulated environment. This role assists in the review, validation, and tracking of equipment, systems, and documentation changes, ensuring compliance with regulatory requirements, data integrity standards, and internal quality procedures.
Key Responsibilities:
Support the review and validation of changes to equipment, systems, and documentation in compliance with cGMP requirements.
Assist in processing and tracking Service Requests related to maintenance and validation activities.
Review maintenance records, change controls, and supporting documentation for completeness, accuracy, and compliance.
Ensure all changes follow established SOPs, cGMP regulations, and data integrity standards.
Support the update and revision of SOPs, maintenance procedures, and work instructions.
Coordinate with Engineering, Maintenance, and Quality teams to support change control and validation activities.
Maintain accurate and audit-ready records of approved changes, Service Requests, and documentation updates.
Identify gaps, discrepancies, or missing information in documentation and support resolution efforts.
Follow up on pending approvals, CAPAs, and assigned action items.
Participate in internal audits, regulatory inspections, and compliance reviews as required.
Utilize CMMS and/or document management systems to track and monitor activities.
Provide administrative and reporting support aligned with validation and quality systems.
Requirements:
Bachelor’s degree in Engineering, Life Sciences, or related field (or in progress).
Basic knowledge of cGMP regulations, validation lifecycle, and change control processes.
Strong attention to detail with a focus on compliance and data integrity.
Good communication skills and ability to work in cross-functional teams.
Familiarity with CMMS, document management systems, or quality systems is preferred.
Must be authorized to work in the United States without sponsorship.
Location:
Puerto Rico
Full-time