We are seeking a highly skilled and detail-oriented Senior GMP Labeling and Packaging Engineer to join our dynamic team. In this role, you will leverage your expertise in quality systems , change management , label lifecycle management , project management , and process improvements to drive compliance, efficiency, and innovation in packaging and labeling. This position requires a strong understanding of regulatory requirements, technical excellence, and the ability to work cross-functionally to support critical business initiatives.

Key Responsibilities

• Quality Systems Oversight :
• Maintain and enhance packaging and labeling quality systems to ensure compliance with FDA, EMA, and related regulations.
• Develop/improve standard operating procedures (SOPs), work instructions, and quality documentation related to packaging and labeling processes with a focus on lifecycle management.
• Change Management :
• Lead and implement change management strategies for packaging and labeling, supporting product lifecycle changes and minimizing operational impact.
• Manage and review label change requests (LCR) to ensure timely, accurate, and compliant label updates.
• Collaborate with regulatory, quality, and manufacturing teams to evaluate and execute changes, supporting a first-time-right approach.
• Project Management :
• Plan, execute, and oversee packaging and labeling projects from concept through implementation, ensuring alignment with product launch timelines and regulatory requirements.
• Develop project scopes, timelines, and resource plans to ensure seamless coordination with cross-functional teams.
• Identify project risks and implement risk mitigation strategies including process improvements, supply chain redundancy, and regulatory compliance.
• Process Improvement :
• Analyze existing packaging and labeling workflows, identify opportunities for process improvements, and implement best practices to increase efficiency and reduce risk.
• Drive continuous improvement initiatives to streamline labeling and packaging processes, enhancing compliance, productivity, and cost-effectiveness.
• Technical Support and Troubleshooting :
• Provide technical expertise and troubleshooting support for packaging and labeling issues, including root cause analysis and corrective action planning.
• Support manufacturing labeling operations including support, issue trending and improvement projects.
• Ensure that all packaging and labeling specifications meet regulatory/process standards.
• Cross-Functional Collaboration :
• Serve as a key liaison between quality assurance, manufacturing , regulatory affairs , manufacturing , and supply chain to align labeling strategies with overall business objectives.
• Support product launches, updates, and regulatory requirements by coordinating with cross-functional teams to achieve timely and compliant product releases.

Qualifications

• Education : Bachelor’s degree in Engineering, regulatory affairs, or a related field.
• Experience : Minimum of 5 years of experience in pharmaceutical packaging and labeling, with specific expertise in sterile injectables and medical devices.
• Regulatory Knowledge : Deep understanding of cGMP, FDA, EMA, and USP guidelines relevant to packaging and labeling, and experience filing label artwork changes.
• Technical Skills : Proficiency with quality systems including change control and quality events, proficiency in labeling equipment, label artwork review and compliance.
• Project Management : Demonstrated success in managing multiple projects in parallel.
• Communication and Collaboration : Excellent communication skills with the ability to work effectively across departments and influence stakeholders.