Summary:
Our client, a biopharmaceutical company located in Cork, is seeking a Manufacturing Process Engineer. The ideal candidate will take responsibility for all equipment related to manufacturing, ensuring it operates to the desired level. The incumbent will work closely with QA, validation, manufacturing and EHS on deviations, equipment improvements, breakdown support, fault finding, vendor liaison and small projects.
Responsibilities: Ensure full compliance with safety regulations and current Good Manufacturing Practices (GMPs). Provide support for the compliance activities of the engineering team within the packaging department. Assist with the introduction and integration of modern technologies (e.g., dispensing, roller compaction, tablet compression, coating) and/or new processes, contributing to the achievement of business goals. Collaborate with the engineering team on the specification, installation, utilization, qualification, and improvement of equipment for solid dose and vial products. Regularly interact with cross-functional teams, addressing equipment-related matters, project implementation, and leveraging support to enhance efficiency programs. Collaborate with engineering and maintenance personnel, including external contractors, to ensure optimal equipment functionality. Contribute to the implementation and development of engineering policies, procedures, techniques, standards, and systems. Prepare and manage project plans, ensuring successful and timely project completion. Support teams in identifying, anticipating, and resolving complex engineering and technology issues in line with industry codes. Drive continuous improvement by proactively seeking ways to enhance engineering processes and optimize manufacturing equipment performance, including improving yield, reducing downtime, and increasing OEE. Analyse data and situations to evaluate factors, identify root causes, and implement corrective actions aimed at meeting business targets related to equipment. Work on routine to moderately complex issues, applying data analysis to evaluate identifiable factors. Collaborate with quality and validation departments to define and maintain the conditions necessary for reliable equipment and manufacturing processes. Adhere to health and safety regulations and procedures at all times, ensuring the safety of both self and others. Qualifications & Experience: Bachelor's degree in a relevant field required. Strong understanding of current Good Manufacturing Practices (GMPs) and safety regulations. Previous experience in solid oral dosage manufacturing is highly desirable. Proficient in Microsoft Office applications (Word, Excel, PowerPoint, etc.).
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