Insight Global is seeking a Senior Project Validation Engineer to support one of our top clients, Johnson & Johnson, a leading general medical device manufacturer in Ciudad Juárez, Mexico.
This individual will be responsible for leading validation activities associated with new and existing components, suppliers, and manufacturing processes.
The engineer will serve as a key liaison between suppliers, manufacturing teams, quality teams, and project stakeholders to ensure successful validation and implementation of products and processes within a regulated environment.
This is a long-term, 2-year contract.
Bachelor's degree in Engineering (Mechanical, Biomedical, Manufacturing, Industrial, or related engineering discipline).
~2-5+ years of experience in Validation Engineering, Manufacturing Engineering, Quality Engineering, or related field.
~ Experience leading validation projects within a regulated manufacturing environment.
~ Strong experience executing validation protocols, engineering builds, qualification runs, and production validations.
~ Experience managing cross-functional projects and coordinating with external suppliers.
~ Hands-on experience utilizing Windchill PLM for product lifecycle management, document control, or engineering change activities.
~ Strong understanding of engineering change processes, validation documentation, and project management principles.




~ Excellent communication skills with the ability to work across manufacturing, quality, engineering, and supplier teams.
~ Medical device industry experience.
Knowledge of FDA, ISO *****, and medical device quality system requirements.
Experience with supplier quality, component qualification, or manufacturing transfers.
Experience supporting new product introductions (NPI) or remediation projects.
PMP, CQE, or other project/quality certifications
Lead validation efforts for supplier-provided components and materials to ensure compliance with quality and manufacturing requirements.
Plan, execute, and document validation protocols and production qualification runs within the manufacturing facility.
Support engineering builds, pilot builds, and production launches while ensuring validation requirements are met.
Collaborate directly with suppliers to resolve technical issues, manage validation activities, and drive project timelines.
Coordinate cross-functional activities with Manufacturing Engineering, Quality Engineering, Supply Chain, and Operations teams.
Track project milestones, risks, deliverables, and validation documentation to ensure successful project execution.
Ensure compliance with applicable quality system requirements and medical device regulations throughout the validation lifecycle.
Provide regular project updates to leadership and key stakeholders.

📌 Senior Project Validation Engineer (Chihuahua)
🏢 Insight Global
📍 Chihuahua