Job Summary
Senior Packaging Engineer—an essential role on the External Manufacturing & Network Equipment team, responsible for overseeing product and technology transfers to Contract Manufacturing Organizations (CMOs) and collaborating with external packaging partners.
Responsibilities
- Support technology transfers, qualifications, validations, process enhancements, and change controls for small and large molecule projects, medical devices, and combination products.
- Ensure compliant packaging and assembly process transfer, project management, site readiness, and execution excellence.
- Coordinate, communicate, and oversee technical matters with external packaging partners autonomously.
- Provide technical support for quality and supply investigations, and co‑lead discussions on packaging processes, equipment, and components to identify root causes and develop corrective and preventative actions.
- Support technical evaluations of external packaging partners and create thorough assessments for partner selection.
- Participate in periodic business review meetings with external packaging partners.
- Lead or support complex changes of packaging images and materials/components.
- Support the qualification of modifications to distribution and thermal transport/storage methods for finished packaging configurations.
Qualifications
- Minimum of 5 years’ experience in medical device or combination product engineering and pharmaceutical field, with 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, with strong GMP and quality systems expertise.
- Solid understanding of scientific or technical concepts for routine and complex tasks, with advanced practical knowledge of applicable techniques.
- Experience with manufacturing change control compliance systems like Veeva and quantitative decision tools for risk management.
- Demonstrated leadership qualities, inclusive practices, and 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.
- Demonstrate commitment to continuous improvement by proactively adopting new strategies, drawing insights from experiences, and making informed decisions regarding risk‑taking.
- Strong analytical and decision‑making abilities, combined with outstanding oral and written communication skills.
- Bachelor’s degree in Packaging Science/Engineering, Mechanical Engineering, or a related technical discipline.
Required Skills
- Change Control Processes
- Driving Continuous Improvement
- Engineering Standards
- Packaging Engineering
- Packaging Equipment
- Packaging Innovation
- Packaging Management
- Packaging Operations
- Packaging Optimization
- Pharmaceutical Packaging
- Sealing Machines
Equal Opportunity Employer
As an equal opportunity employer, we are proud to be a company that embraces the value of bringing inclusive, talented, and committed people together.