Project Engineering Specialist - 61003 (Añasco)

Title: Project Engineering Specialist - 61003 (Añasco) Job Type : Professional services contract. Duration: Depends on project schedule. Expected 1 Year Where : Añasco, On-Site Hour Rate: Depends on the expertise. Negotiable Details: Lead and execute labeling update projects within a regulated medical device manufacturing environment. To implement labeling changes, coordinate project activities, execute validation efforts, and ensure compliance with quality and regulatory requirements. Responsible for managing labeling-related change controls, assessing risks and compliance impacts, validating labeling equipment and systems as required, and driving projects from initiation through implementation and closure. The ideal candidate is a hands-on professional with strong project management, technical writing, problem-solving, and communication skills, along with a continuous improvement mindset. Responsibilities: Lead and execute labeling update projects, ensuring timely implementation and compliance with applicable regulatory and quality requirements. Manage labeling-related change control activities from initiation through closure, including implementation planning, documentation updates, verification, stakeholder communication, and effectiveness checks. Coordinate cross-functional activities with Quality, Regulatory Affairs, Operations, Manufacturing, Supply Chain, Product Development, Engineering, and IT teams. Author, review, and execute validation documentation, including validation plans, protocols, test scripts, reports, risk assessments, and impact assessments, as required. Develop and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities for labeling equipment, printing systems, software, and related processes, when required. Support qualification and implementation of new label materials, printers, barcode systems, vision systems, and labeling software, when required. Investigate and resolve issues encountered during labeling updates, validation activities, or implementation efforts. Assess existing labeling processes and documentation as required, identify risks, gaps, and compliance concerns, and recommend corrective or preventive actions. Develop, maintain, and monitor project schedules using Microsoft Project and provide regular status updates to stakeholders, as required. Drive continuous improvement initiatives focused on labeling processes, project execution, compliance, and operational efficiency. Ensure all project documentation complies with company procedures, GMP requirements, quality system standards, and data integrity expectations. Utilize Microsoft Office applications to support project planning, reporting, documentation, data analysis, and presentations. MINIMUM QUALIFICATIONS Education and/or experience: Bachelor’s degree in Industrial Engineering, Mechanical Engineering, Biomedical Engineering, or a related technical discipline. Minimum of 5 years of experience in validation, labeling, quality, manufacturing, or other regulated industry environments. Demonstrated experience leading and executing labeling update projects. Experience with change control processes and project lifecycle management. Experience validating labeling equipment, including printers, barcode systems, vision systems, and labeling software. Working knowledge of FDA Quality System Regulations (QSR), ISO 13485, ISO 9001, GMP requirements, or equivalent regulated environments. Experience creating and executing validation protocols and reports. Experience using Microsoft Project for planning, scheduling, tracking, and executing projects. Experience with Product Lifecycle Management (PLM) systems such as Agile PLM and ERP platforms such as Oracle or equivalent systems. Strong analytical, problem-solving, risk assessment, organizational, and technical writing skills. Strong verbal and written communication skills and ability to work effectively within cro…

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