Summary
Our client is a bio pharmaceutical company based in Cork looking for a Process Engineer to join the team.
The successful candidate 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
Provide technical engineering support and expertise to Packaging & Labelling Operations including equipment performance monitoring, equipment recipe standardisation troubleshooting and process optimisation
Represent Engineering on the Packaging & Labelling Operations Process Team and support to deliver uninterrupted supply of commercial product.
Fulfil system ownership responsibilities for all packaging equipment and associated automation recipes required for packaging operations
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 capital project team on design, qualification, cycle development and GMP release.
Implementation of 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 investigations, 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.
Participate in cross-functional project teams to ensure project and site stakeholder inputs and requirements are clear and reflected in design deliverables.
Required to comply with Company Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities.
Ensure relevant documentation is prepared and updated in line with all Quality and regulatory guidelines and promotes full compliance to all GMP, environmental and safety requirements.
Instil the use of Right First Time (six-sigma) and lean manufacturing practices leading to operational excellence.
Ensure adherence to high standards of quality and support of a science and risk based quality culture.
Providing coaching and support to the Operations team to build their knowledge of packaging processes and associated recipes.
Ensures that all manufacturing methods and practices are consistent with industry standards.
Maintains professional and technical knowledge by attending workshops, reviewing professional publications; establishing professional networks and participating in professional societies.
Qualifications & Experience
Degree in Engineering – Process, Chemical, Mechanical or equivalent discipline
Qualification in Six Sigma, Lean Manufacturing would be an advantage
8+ years' experience working in a process manufacturing or capital projects role within a GMP environment is required
Experience on packaging projects would be a distinct advantage
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