Labeling/Packaging Engineer

4 days ago

North Billerica, United States Randstad Life Sciences US Full time

A major Pharmaceutical company advancing patient care by learning, adapting and making advancements across the healthcare spectrum. Reaching further with novel therapeutics and AI technologies and continuing to forge ahead with new solutions to new problems—always knowing that someone’s health is in our hands.

For the ideal candidate, we are looking for someone in the 8-15 year experience range as a label/packaging engineer. Specifically, the candidate needs to be highly autonomous, and able to bring some industry best practices to our company.

Project I:

  1. Take on current scope of work for labeling execution
  2. Multiple label artwork change projects in flight
  3. Supply continuity planning for 2nd source labels (procurement, design, test)
  4. Labeling deviation support

i. Complaints investigations (mostly peeling labels)

ii. Ops support (mostly equipment)

Project II:

  1. Long term labeling systems review/gap assessment/improvement
  2. MFG operations process improvements
  3. Label lifecycle improvements
  4. Product launch support (in house and outsource products)

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.

Job 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.

Education & 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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