Manufacturing Process Engineer

Job Overview

A prominent biopharmaceutical organization located in Waterford seeks a Manufacturing Process Engineer to provide expert technical leadership and comprehensive process engineering assistance within their manufacturing operations. Working in a GMP-controlled setting, the engineer will spearhead initiatives to enhance processes, promote continuous improvement, and uphold operational excellence. The role entails collaboration with Manufacturing, Quality, Engineering, and Supply Chain teams to optimize manufacturing workflows and ensure dependable product delivery.

Key Responsibilities

• Offer process engineering expertise across manufacturing and development functions operating under GMP standards.
• Collaborate with various internal and external parties to refine manufacturing methods and boost operational efficiency.
• Identify, create, and deploy initiatives focused on continuous improvement to increase manufacturing quality, productivity, and efficiency.
• Assist in the planning, supervision, and execution of capital projects related to manufacturing facilities.
• Lead thorough troubleshooting efforts, root cause analyses, and effective corrective action implementations.
• Drive efforts to reduce cycle times and support adoption of best manufacturing practices.
• Develop and manage process development programs including plant trials and optimization activities.
• Serve as Subject Matter Expert on manufacturing processes, quality attributes, and critical process parameters.
• Assist with new product launches, improvement of formulations, and enhancement projects.
• Engage in technology transfer and scale-up operations aiding manufacturing throughput.
• Support manufacturing activities related to clinical supply production when necessary.
• Design and perform experiments to advance process development and enhance manufacturing capabilities.
• Contribute to process lab functions and analyze manufacturing performance metrics.
• Conduct investigations into complaints, deviations, laboratory investigation reports, and CAPAs ensuring timely resolutions.
• Create, review, and uphold manufacturing documentation adhering strictly to GMP compliance.
• Track manufacturing KPIs and highlight potential areas for operational improvements.
• Ensure adherence to current GMP, quality, and regulatory mandates throughout all tasks.

Qualifications and Skills

• Bachelor’s degree in Chemical Engineering, Industrial Engineering, or related engineering fields.
• Advanced credentials in Pharmaceutics, Pharmacy, or related scientific domains are favorable.
• Prior experience working in pharmaceutical or biotech manufacturing within GMP environments.
• Strong knowledge of manufacturing processes, optimization techniques, and continuous improvement strategies.
• Experience in new product introduction, process development, and technology transfer projects.
• Familiarity with aseptic manufacturing and lyophilisation is beneficial.
• Competency in Design of Experiments (DoE) and statistical analysis methods.
• Experience handling manufacturing investigations, deviations, CAPAs, and change control procedures.
• Exposure to laboratory or pilot plant settings is advantageous.
• Highly developed project management, organization, and communication abilities.
• Proficiency with Microsoft Office and technical documentation preparation.