Process Engineer

About the Role

A pharmaceutical client based in the Waterford Metropolitan Area is seeking an experienced Process Engineer to provide leadership and support to operations teams ensuring compliance with quality and operational standards. The role involves developing and implementing process improvements across manufacturing and development functions.

Key Responsibilities

• Collaborate with both internal and external stakeholders including customers, suppliers, and agencies to enhance manufacturing and development processes.
• Identify opportunities to optimize manufacturing and development operations and lead improvement initiatives.
• Support the implementation of capital projects aimed at operational advancement.
• Serve as the process lead for inspection development activities.
• Lead root cause analysis (RCA) and technical problem-solving efforts across manufacturing operations with cross-functional teams.
• Implement and track performance metrics to measure operational effectiveness.
• Drive cycle time reduction projects in coordination with manufacturing teams.
• Champion best practices adoption to improve process efficiency and quality.
• Design, execute, and implement process development programs and plant trials.
• Continuously evaluate and challenge existing operational standards to promote continuous improvement.
• Manage multiple tasks effectively and prioritize workloads efficiently.
• Ensure all quality documentation remains compliant and up to date.
• Act as a subject matter expert (SME) for new product introductions and enhancement development projects.
• Provide expertise and resource support for clinical supply provisioning projects.
• Experience in aseptic or oral dose manufacturing environments is essential.
• Serve as SME for product quality attributes and critical process parameters.
• Plan and conduct experimental programs to support process improvements.

Qualifications and Skills

• Bachelor's degree in Chemical, Industrial, or an equivalent Engineering discipline.
• Advanced degree in Pharmaceutics, Pharmacy, or related science field is advantageous.
• Technical understanding of aseptic manufacturing processes, including lyophilisation, is highly desirable.
• Proficiency in Design of Experiments (DOE) and associated statistical methodologies.
• Knowledgeable about pharmaceutical product development life cycle.
• Strong skills in report writing and verbal communication.