Packaging Development Engineer
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Job Type | Fixed Term |
Area | Dublin |
Sector | Operations & Manufacturing |
Start Date | |
Advertiser | Lisa O'Connor |
Job Ref | 2337 |
Job Views | 967 |
- Description
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.