Packaging Development Engineer
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| Job Type | Contractor |
| Location | Dublin |
| Area | Dublin, Ireland |
| Sector | EngineeringOperations & Manufacturing |
| Start Date | |
| Advertiser | Darcy Ainscough-Denton |
| Telephone | +353 1 574 6266 |
| Job Ref | 2836 |
| Job Views | 145 |
- Description
- Team Horizon is seeking a Packaging Development Engineer (initial 12-month contract) for our client who are a global leader in the biopharmaceutical industry. In this role you will join the Technical Services team for Ireland and you will have packaging oversight at Contract Manufacturing Organisations (CMOs) used by the client to produce commercial and clinical drug product. This position provides strong packaging engineering support through all phases of the commercial finished product lifecycle, including technology transfer, validation, and routine Finished product (FP) commercial manufacturing.
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.
Our client has developed a stand-out culture of innovation, inclusion, and development, and consistently features as a great place to work.
Join a team who build and maintain effective cross-functional working relationships with groups finished product (FP) subject matter experts, New Product Introduction (NPI), Internal/External Manufacturing Operations, Quality, Marketing, medical devices, and Regulatory partners for technology transfers of new and existing products.
What you will be doing:
Ownership of the commercial packaging relationship with our contract manfactuters.
Leading troubleshooting and root cause analysis activities for critical issues at CMOs
Using lean six-sigma expertise to identify, analyse and prioritise optimisation at the FP level
Ensuring that all processes are appropriately validated and approved for manufacturing and partner with regulatory and QA colleagues to ensure that processes are maintained in a validated state and adhered to throughout their lifecycle.
Supporting the generation and review of oversight group input to sections of the BLA and other technical documents for regulatory agency submission for commercial CMO sites.
Review, approve corrective/Improvement actions from Lifecycle change management as required
Communicating operational status of CMOs regularly to management, as required, at the appropriate level of detail, both orally and using written documents, and in formal and informal presentations.
Up to 20% international travel may be required
Any other duties as assigned.
What you need to apply:
Minimum of Bachelors degree in engineering (or similar technical Bachelors degree).
Comprehensive understanding of cGMP requirements for commercial manufacturing.
Excellent communication and influencing skills enabling him/her to influence both internal and external partners.
Ability to present and defend technical aspects of manufacturing operations during regulatory agency inspections.
We would prefer for you to have:
Exposure to Project Management principles and tools.
Experience of MS Project or other project management software.
Exposure/experience of some packaging systems within a GMP environment – Stability, Change Control, Packaging processes, Serialization, ERP Inventory Systems.
