Packaging Development Engineer

Packaging Development Engineer – Team Horizon
We are seeking applications for an experienced Packaging Development Engineer to join our client site in Dublin on an initial 12-month contract.
 
Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.

 
What you will be doing:

• Liaise with the global team to create the best packaging form, fit, function and aesthetics for state of the art and new drug products under the 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 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 and ongoing packaging activities in commercial remit for vial packaging and Combination Drug Devices/Vials.
• 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 trouble shooting activities to support manufacturing during FP transfer activities or routine FP manufacturing
• Collaborate effectively with other team members in cross functional technology transfer teams, including with FP external manufacturing partners and internal FP manufacturing stakeholders

What you need to apply:

• Minimum of two years’ experience in providing technical support to Finished Product manufacturing (technology transfer or routine cGMP manufacturing).
• Minimum of bachelor’s degree in engineering (or similar technical bachelor’s degree) (advanced degree preferred)
• 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.
• Six sigma training/certification
• Up to 25% international travel required.