Randstad Life Sciences US | Labeling Engineer | billerica, ma
5 days ago
Hourly Pay: $70 an hour
Job Summary
We are seeking a highly skilled and detail-oriented Senior Packaging and Labeling 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.
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