21205818-Packaging Engineer-Dublin Contractor

This role is on a 12 month contract initially with a view to extension.

Purpose

The successful candidate will have packaging oversight at Contract Manufacturing Organisations (CMOs) to produce commercial and clinical drug products. 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. As a team, we build and maintain effective cross-functional working relationships with groups of 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.

Responsibilities

• Ownership of the commercial packaging relationship with our contract manufacturers.

• Lead 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 partnering 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, and approve corrective/Improvement actions from Lifecycle change management as required.

• Communicating the 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% of international travel may be required.

Requirements

• Minimum of bachelor’s degree in engineering (or similar technical bachelor’s 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.

• Exposure to Project Management principles and tools.

• Experience with MS Project or other project management software.

• Exposure/experience with some packaging systems within a GMP environment – Stability, Change Control, Packaging processes, Serialization, ERP Inventory Systems.