Validation Specialist Packaging

Job Title: Validation Specialist – PackagingLocation: Anasco, PR (On-site)Duration: 6 Months (Possible Extension)Pay Rate: $33/hr on W2
RequirementsBachelor's degree in Engineering (Packaging, Mechanical, Biomedical, Industrial, or related).4+ years of validation/manufacturing experience in a regulated industry.Hands-on tray-sealing process experience (Must Have).Packaging validation and protocol execution (IQ/OQ/PQ).Medical device, pharma, or biotech experience.Knowledge of FDA QSR, ISO 13485, GMP, and ISO 9001.Experience working in ISO 7 cleanroom environments.Strong documentation and Microsoft Office skills.Must be flexible to work weekends and different shifts as needed.
ResponsibilitiesExecute packaging validation and testing activities.Prepare validation protocols, reports, and documentation.Collect and analyze validation data.Support packaging line trials and engineering projects.Work with Quality, Regulatory, Operations, and Engineering teams.Ensure compliance with FDA and ISO requirements.