MSD Project Engineer Assoc Dir 

Ireland 

538545752

Job Description

The facility is designed to be operated in a multi-product mode which requires flexibility to adjust as the pipeline of clinical and commercial biologics-based medicines demands change. A multi-product strategy for equipment design and implementation will enable the facility to adapt in a flexible and agile way for rapid product launch.

Key responsibilities will include:

• Responsible for the successful execution of Engineering projects designed to deliver robust and optimized manufacturing processes, as well as the provision of day-to-day technical support and expertise to the operations teams.
• Apply a project management approach for successfully project delivery, from scope development, resource planning, stakeholder alignment, project execution and closeout.
• Lead process & project decisions based on risk and the interpretation of data sets ensuring consultation and communication with stakeholders.
• Lead the timely introduction of new processing technologies for routine full-scale manufacture, inclusive of validations ensuring a cost effective, compliant, and robust process is achieved.
• Provide technical support and expertise as required to achieve process optimisation. Identify and generate opportunities for improvement and actively participate in the implementation of corrective action plans and continuous improvement initiatives.
• Liaise closely with Process engineering, Tech transfer and Operation teams for project identification and lead cross functional.
• In partnership with Process Automation actively support Digital Transformation initiatives in a cGMP environment involving system integrations, data connectivity, and simplification.
• Conduct investigations; equipment and process related troubleshooting, and root cause analysis, implementing appropriate corrective and preventative actions where necessary.
• Support all departments, particularly Safety & Quality, and Operations in relation to Engineering changes.
• Demonstrate a high level of accountability and ownership for performance.
• Train, coach, and mentor colleagues on new technologies and/or manufacturing processes.
• Ensure highest Quality & Compliance standards, participating and complying with the Quality Management System and Quality Risk Management.
• Comply with all company policies and procedures, including quality requirements, financial controls, health, and safety regulations.
• Top of Form

Your profile

• Engineering degree or equivalent with min 10 years’ experience.
• Demonstrated experience in a GMP-regulated large molecule drug substance manufacturing environment, ideally with experience of single-use systems.
• Proven experience in a leadership role managing projects in the biotech sector, from scope development through qualification, validation, and operation.
• Possess a deep technical understanding of a manufacturing/operational GMP (Good Manufacturing Practice) environment with detailed knowledge and experience of both upstream and downstream processing being a significant advantage.
• Delta V and MES (Manufacturing Execution System) knowledge and experience an advantage.
• Effective oral / written communication skills in English.

So, if you are ready to:

Current Contingent Workers apply

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