Senior Packaging Engineer
HybridDublin, Leinster, Ireland
Job Summary
Oversee product and technology transfers to Contract Manufacturing Organizations, coordinating technical matters with external packaging partners autonomously. Execute primary and secondary packaging components for Small and Large Molecule assets and Medical Device Combination Products, while designing packaging equipment and ensuring process control. Support technology transfers, validations, and change controls for new and existing facilities, leading root cause analysis for quality and supply investigations. Lead discussions on packaging processes and materials, including complex changes to distribution and thermal transport methods. Ensure compliant packaging and assembly process transfer, driving continuous improvement within cross-functional teams.
Required Qualifications
- Minimum of 5 years' experience in medical device or combination product engineering and pharmaceutical field
- practical knowledge in packaging operations, materials, and processes
- Experience in capital packaging equipment projects, including technology transfers, designing packaging lines, equipment installation and validation, and troubleshooting
- Experience with devices and combination products, covering design control to product and technology transfer for both new and existing packaging facilities
- Proficiency in project management from conception to closeout
- strong GMP and quality systems expertise
- Solid understanding of scientific or technical concepts for routine and complex tasks
- advanced practical knowledge of applicable techniques
- Experience with manufacturing change control compliance systems like Veeva
- quantitative decision tools for risk management
- Demonstrated leadership qualities
- ability to work in a diverse, cross-functional team
- Familiarity with the regulatory standards of key pharmaceutical markets, such as USFDA, cGMPs and EMA guidelines
- Bachelor's degree in Packaging Science/Engineering, Mechanical Engineering, or a related technical discipline
- Valid Driving License
Desired Qualifications
- Commitment to continuous improvement by proactively adopting new strategies, drawing insights from experiences, and making informed decisions regarding risk-taking
- Regard setbacks as valuable learning opportunities rather than impediments
- Adopt a critical mindset in decision-making to ensure thorough analysis while considering potential impacts on key stakeholders
- Strong analytical and decision-making abilities
- outstanding oral and written communication skills
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.