14967320 – Packaging Development Engineer – Dublin Contractor

This is a 12-month contract with our Pharmaceutical client in Dublin.

Note – The role allows for hybrid or remote working

Responsibilities

• Liaise with the global team to create the best packaging form, fit, function, and aesthetics for state-of-the-art and new drug products brand.
• Perform Finished Product (FP) technology transfer for assigned projects from clinical stages into cGMP commercial FP manufacturing facilities and launch.
• Using quality by design principles to collaborate and build a world-class process for packaging development within the company using internal mechanisms for procedural development, guidance documents, and specifications.
• Responsible for performing process evaluation, facility fit analysis, and identification of equipment required for new FP manufacturing processes, either independently or in partnership with external FP manufacturing personnel.
• Acting as the technical SME for packaging transfers including global approval of multi-language transfer protocols and reports.
• Support alignment of FP processes across internal and external FP manufacturing sites.
• Support ongoing packaging activities in the commercial remit for vial packaging and Combination Drug Devices/Vials.
• Ownership of Change Control and Risk Assessment as applied to Packaging Transfers.
• Support resolution of complaints and liaise with vendors to resolve issues, investigations, and implement continuous improvements.
• Review FP technology transfer documentation; e.g. validation run protocols, and technical study protocols.
• Provide FP SME input for regulatory agency submission in support of FP manufacturing processes at internal/external FP manufacturing sites.
• Provide packaging engineering expertise in troubleshooting activities to support manufacturing during FP transfer activities or routine FP manufacturing.
• Identify and lead FP process optimization initiatives and address opportunities for efficiency and capacity improvements in all areas of FP manufacturing.
• Identify FP manufacturing best practices across the network and lead or participate in teams to implement best practices.
• Collaborate effectively with other team members in cross-functional technology transfer teams, including with FP external manufacturing partners and internal FP manufacturing stakeholders.
• Implement business process improvements with a continuous improvement mindset for FP manufacturing support and FP tech transfers.
• Partner with product teams on optimal packaging design considering the end-user/patient, supply chain, and FP manufacturing network capabilities.

Requirements

• Minimum of Bachelors degree in engineering (or similar technical Bachelors degree) (advanced degree preferred).
• Six Sigma training/certification.
• Experience with project/program management and tech transfers.
• Experience in working with external FP manufacturing partners would be a distinct advantage
• Up to 25% international travel is required.
• Minimum of two years experience in providing technical support to Finished Product manufacturing (technology transfer or routine cGMP manufacturing).
• Comprehensive knowledge of Finished Product manufacturing operations including blister packs, vial packaging, pre-filled cartridge packaging, and combination devices packaging.
• Good understanding of cGMP requirements for commercial manufacturing.
• Proven ability to work independently and to build highly effective relationships both within and external to the company.
• Organized analytical thinker with strong attention to detail.
• Excellent oral and written communication skills, including technical writing.
• Experience of working with external FP manufacturing partners would be a distinct advantage.
• Quality mindset.