Senior Validation Engineer
Sobre el proyecto y el rol
#506 Eap - senior validation engineer (csv / manufacturing – fda regulated) Client: Carestream Rate: $1per hour Globant recruiter: jesica.cywiner@globant.com English: B2 | Medium +, C1 | Advanced - Duration: 6 Dedication: Contractor Vacancies: 1 All seniorities & countries: Senior, senior level 2, Architect, software designer, Latam Project description We are looking for a Senior Validation Engineer to lead validation and integration strategies that ensure manufacturing equipment, computerized systems, utilities, and processes comply with applicable regulations, company policies, and industry standards. You will lead Computer System Validation (CSV) in a medical device manufacturing environment, in line with 21 CFR Part 820, 21 CFR Part 11, and ISO 13485, and act as a technical reference during FDA audits. Main tasks Lead end-to-end CSV and process validation projects: strategy, plans, protocols (IQ/OQ/PQ), traceability matrices, and summary reports. Validate manufacturing systems, equipment, and enterprise applications (e.g., MES, ERP, QMS) following GAMP 5 and a risk-based approach. Ensure compliance with 21 CFR Part 11 (electronic records and signatures, audit trails, data integrity) and HIPAA for systems handling protected health information. Represent Validation in FDA inspections and audits: prepare documentation, respond to observations, and support CAPAs. Partner with Manufacturing, IT/IS, Quality, and Engineering teams to promote validation best practices. Coordinate and report on validation tasks, risks, and deliverables; mentor junior engineers. Required skills Required Qualifications BS or higher in Engineering, Computer Science, or an equivalent technical field. 10+ years of experience in computer system validation within an FDA- regulated industry (medical devices preferred). Strong knowledge of 21 CFR Part 820, 21 CFR Part 11, ISO 13485, GAMP 5, and SDLC methodologies. Proven experience validating manufacturing systems and enterprise platforms (e.g., SAP, Oracle, MasterControl). Working knowledge of HIPAA and regulations impacting medical information systems. Hands-on experience supporting or leading FDA audits. Excellent communication skills and the ability to work