Senior Process Engineer

2 weeks ago

Cork, Cork, Ireland Fastnet Full time

Senior Process Engineer will be responsible for ensuring process engineering activities are implemented in a compliant manner.
Provide process engineering services to Manufacturing in a Biologics Drug Substance, Drug Product Filling, Packaging and Labelling facility.

Responsibilities :
Provision of technical engineering support to Drug Product Filling operations including process performance monitoring, troubleshooting process investigations and process optimisation.
Fulfil system ownership responsibilities for assigned Drug Product Filling equipment including production recipe and cleaning recipe updates where required.
Provide technical engineering support for process fit to plant workshops to ensure successful technology transfers of new products Participate in cross-functional project teams to ensure project and site stakeholder inputs and requirements are clear and reflected in design deliverables and support qualifications as required.
Lead and participate in cross-functional teams to troubleshoot and resolve technical issues, drive continuous improvement and process optimisation using tools such as DMAIC, SMED and FMEA.
Requirements :
BA Degree in Engineering - Process, Chemical, Mechanical or equivalent discipline Other continuing education initiatives highly desirable - Six Sigma, Lean Manufacturing, industry specific coursework 5-8 years of leading engineering initiatives in a GMP/GCP compliant environment.
Biopharma operations experience required.
3+ years of directly related experience in Filling Operations.
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