Manufacturing Process Engineer - Drug Substance

Overview

We are seeking a Process Engineer to join a biopharmaceutical firm based in West Dublin, focusing on supporting drug substance manufacturing processes. This role emphasizes providing technical expertise across manufacturing operations and driving process improvements to enhance performance while ensuring GMP compliance.

Key Responsibilities

• Deliver technical assistance throughout the drug substance manufacturing lifecycle.
• Facilitate the adoption and implementation of Event Frames for enhanced process monitoring and data visualization.
• Support all aspects of technology transfer, scale-up, process validation, and commercial manufacturing.
• Work collaboratively with Operations, Technical Services, QA, Automation, and Data Analytics to advance manufacturing projects and operations.
• Gather, organize, analyze, and trend GMP manufacturing data using statistical methods to uncover improvement opportunities.
• Diagnose manufacturing challenges and partner with site teams to develop and implement corrective solutions.
• Lead continuous improvement initiatives aimed at boosting manufacturing efficiency, process capability, and operational outcomes.
• Assist ongoing process monitoring activities and propose process enhancements based on data insights.
• Participate in cross-functional projects adhering strictly to GMP regulations and site protocols.
• Maintain technical documentation accuracy and support engineering inquiries as needed.

Qualifications and Experience

• Degree in Chemical, Mechanical, Pharmaceutical Engineering, Science, or related field.
• Proven experience in pharmaceutical or biopharmaceutical manufacturing environments.
• Hands-on experience with manufacturing process support including technology transfer, validation, or scale-up.
• Understanding of GMP manufacturing practices and quality systems.
• Familiarity with Functional Design Specifications and process mapping.
• Strong analytical ability with a track record of managing and interpreting manufacturing data.
• Advanced proficiency in Microsoft Excel; knowledge of Word and PowerPoint.
• Excellent communication skills and ability to manage stakeholder relationships effectively.
• Experience with quality management systems like TrackWise, EQV, or deviation management is a plus.
• Knowledge of project management principles and continuous improvement methodologies such as Lean or Six Sigma is advantageous.
• Demonstrated initiative in identifying and driving process enhancements in manufacturing operations.