Process Engineer
4 weeks ago
Process Engineer
12 Month Contract
Cork
Role Summary:
Reports to the Senior Manager and is responsible for ensuring process engineering activities are implemented in a compliant manner. Provides process engineering services to Manufacturing in a Biologics Drug Substance, Drug Product Filling, Packaging and Labelling facility.
Responsibilities:
- Provide technical engineering support and expertise to Packaging & Labelling Operations including equipment performance monitoring, recipe standardisation troubleshooting, and process optimisation.
- Represent Engineering on the Packaging & Labelling Operations Process Team and support the delivery of uninterrupted supply of commercial products.
- Fulfil system ownership responsibilities for all packaging equipment and associated automation recipes required for packaging operations.
- Act as the Process Engineering system owner representative on key capital projects for area expansion currently being implemented in Packaging across different suites. Provide SME input as part of the capital project team on design, qualification, cycle development, and GMP release.
- Implement equipment recipe updates required for artwork updates, SKU launch activities, and technology transfers of new products.
- Lead and support the investigation and resolution of equipment issues, ensuring appropriate and effective CAPAs are put in place.
- 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.
- Provide coaching and support to the Packaging Operations and Process Engineering team to build their knowledge.
- Partner with serialisation SMEs to ensure Packaging is ready to meet changing global requirements.
Requirements:
- BA Degree in Engineering - Process, Chemical, Mechanical, or equivalent discipline.
- Other continuing education initiatives are highly desirable - Six Sigma, Lean Manufacturing, industry-specific coursework.
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