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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