Jr. Validation Resource

Job Description About 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.ABOUT THE ROLEWe are looking for a detail-oriented and motivated Junior Validation Resource to support change management, documentation review, and service request processing activities within a GMP-regulated pharmaceutical manufacturing environment.You will collaborate with Engineering, Maintenance, and Quality teams to ensure that changes to equipment, systems, and procedures are properly validated, documented, and compliant with regulatory standards. This is an excellent opportunity to build a strong foundation in pharmaceutical validation, change control, and documentation practices.RESPONSIBILITIESChange Validation Support: Support the review and validation of changes to equipment, systems, and documentation under supervision, ensuring compliance with established procedures and regulatory requirements.Service Request Processing: Assist with the processing and tracking of Service Requests related to maintenance activities, ensuring timely follow-up and accurate documentation.Documentation Review: Review maintenance records, change requests, and supporting documentation for completeness, accuracy, and regulatory compliance.Procedure Updates: Support updates and revisions of maintenance procedures and work instructions in alignment with current practices.Cross-Functional Coordination: Coordinate with Engineering, Maintenance, and Quality teams to gather required information for change validations and documentation updates.Record Maintenance: Maintain organized records of approved changes, Service Requests, and procedure revisions to ensure audit and inspection readiness.Gap Identification: Assist in identifying gaps, inconsistencies, or missing information in submitted documentation, escalating findings as appropriate.CMMS Utilization: Use maintenance management systems (CMMS) or tracking tools to log, monitor, and report on requests and pending action items.Administrative Support: Provide administrative and reporting support related to maintenance and change control activities, including participation in audits and internal reviews as needed.REQUIREMENTS & QUALIFICATIONSRequiredBachelor's degree in Engineering (Mechanical, Electrical, Chemical, or Industrial), Life Sciences, or a related technical field.Familiarity with GMP regulations and quality documentation practices in a regulated manufacturing environment.Ability to review technical documentation for completeness and accuracy.Basic understanding of change management and document control processes.Proficiency in Microsoft Office 365 (Word, Excel, Outlook, Teams).Bilingual in English and Spanish (oral and written).PreferredPrior internship, co-op, or hands-on experience in a pharmaceutical, biotech, or medical device manufacturing environment.Exposure to CMMS platforms (e.g., SAP PM, Maximo, or similar) for work order and service request tracking.Familiarity with validation lifecycle concepts (IQ, OQ, PQ) or 21 CFR Part 11.Experience supporting internal audits or quality inspections.SKILLSTechnical SkillsGMP documentation review and change control fundamentalsService Request and work order processingMaintenance procedure revision and document controlCMMS platforms — SAP PM, Maximo, or equivalentAudit and inspection readiness documentationMicrosoft Office 365 — Word, Excel, Outlook, TeamsSoft SkillsHigh attention to detail and accuracy in documentationOrganized and methodical approach to task managementProactive communication and follow-up disciplineEagerness to learn and apply GMP principles in a regulated environmentCollaborative team player with a quality-first mindsetReliable and accountable in time-sensitive deliverables