Jr. Validation Resource
JC Automation Corp•Barceloneta, PR
About The Position
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.
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.
Nice To Haves
- Familiarity with CMMS, document management systems, or quality systems is preferred.
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.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
11-50 employees
