Project Engineer III – Labeling Projects (2622)

MedChem Engineering Services LLC is a recruiting and staffing company dedicated to helps companies recruit and manage contingent workers by providing the best talent in the industry for every client needs. MedChem operates in Puerto Rico. For more information, please visit our website: www.medchemengineeringservices.com We are seeking a Contractor Project Engineer to lead and execute labeling update projects supporting the Project Engineering Department within a regulated medical device manufacturing environment. This role partners closely with Project Engineering, Quality, Regulatory Affairs, Operations, and other cross-functional teams to implement labeling changes, coordinate project activities, execute validation efforts, and ensure compliance with quality and regulatory requirements. The specialist will be 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. Candidates must be proficient in English (written and verbal) and be available to support multiple shifts and weekend activities as business needs require. Key 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. Required Qualifications 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 v…

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