The Process R&D Engineer will work in collaboration with an R&D team to develop continuous and batch processes for active pharmaceutical ingredient (API) manufacturing using a variety of unit operations. The candidate will help design and set-up equipment to support the process development at lab scale. With the help of chemists, the Process R&D Engineer will collect the data necessary for modelling to gain a fundamental understanding of the process and support process optimization. The Process R&D Engineer will assist in scale up activities and be closely involved with transfer of the process to the full-scale plant. The candidate will also provide support to commercial manufacturing. Works under only general direction. This position is not remote or hybrid.
Duties and Responsibilities
• Development of modelling solutions for the scale-up and optimization of processes.
• Monitors existing processes, ensuring that batch records are maintained, variances are investigated, and day to day activities are properly planned.
• Troubleshoots processes to reduce downtime, improve cycle time, and increase productivity.
• Survey and evaluate new technologies.
• Implementation of technologies for safer and more efficient operating conditions.
• Interface with R&D Scientists and Engineers to transfer processes from the lab to the plant.
• Activates and qualifies facilities and equipment.
• Conducts product changeovers through shift coverage, preparation of cleaning instruction, and leading in set up operations.
• Write procedures and batch records.
• Develops process training for operations.
• Assists in the completion of Process Safety information and participates in Process Hazard Analysis.
• Interface with customers.
EDUCATION AND EXPERIENCE
• Typically requires 5-8 years of related experience and a bachelor's degree or 3-6 years of related experience and a master's degree or 0-3 years of related experience and a PhD degree or equivalent experience.
• BS, MS or PhD degree in Chemical Engineering;
• 5-8 years of industrial experience in Process R&D highly desired;
• Experience in cGMP manufacturing for pharmaceuticals highly desired
COMPETENCIES/SKILLS
• Strong knowledge of thermodynamic, mathematical modelling and process optimization;
• Strong written and communication skills;
• Knowledge of Organic Chemistry preferred;
• Knowledge of computer programming for equipment control and automation preferred;
• Ability to multi-task and handle multiple projects;
• Organized and safety conscious
This job description does not constitute a contract of employment or otherwise limit employment-at-will rights at any time.
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