Senior Process Engineer

Job Overview

As an expert in their field, the Senior Process Engineer leads technical teams responsible for the manufacture of active pharmaceutical ingredients. The senior engineer oversees multi-step, multi-year programs that define the cGMP manufacturing process for active pharmaceutical ingredients. They are an engineering expert, interfacing with internal leadership and external clients to solve complex technical problems and ensure high-quality manufacturing.

Responsibilities

• Lead multi-step, multi-year technical programs for the development of the manufacturing process for an API from the initial pilot batches to full commercialization.
• Oversee the conceptual process design for complete API programs including: scaling calculations for unit operations, equipment selection, production planning, and determination of operating parameters.
• Lead process reviews for operability, safety, and quality.
• Operate as a subject-matter expert for external clients and internal stakeholders.
• Mentor junior engineers and scientists.
• Initiate improvements through ideation, process modelling and the analysis of production and laboratory data.
• Lead complex quality investigations and corrective action / preventative action implementation.
• Identify, oversee, and conduct process improvement projects to reduce cycle time, increase yield, and improve quality.
• Coordinate the drafting of manufacturing documents: process flow diagrams, batch records, validation protocols, standard operating procedures, quality investigations, campaign reports.
• Optional Additional Responsibility: Lead a team of 2-5 engineers as direct reports, overseeing career development and project assignments.

Qualifications/Skills

• Applied Math and Science: A complete understanding of the core chemical engineering fundamentals (thermodynamics, heat transfer, mass transfer, transport, kinetics, etc.) and an intuitive sense for their application to real-world problems.
• Data Analysis, Visualization, Troubleshooting: The ability to analyze data from various sources, including sensors and experiments, to identify trends, troubleshoot issues, and improve efficiency.
• Process Simulation and Modeling: Advanced use of software (spreadsheets, programming, simulators) to model chemical unit operations and processes.
• Process Safety and Risk Management: Instinctively assess and manage risks associated with chemical processes, ensuring the safety of personnel and the environment.
• Process Scale Up & Equipment knowledge: Assess equipment capability of key processing equipment (reactors, filters, heat exchangers) with respect to process fit. Proposes alternatives that incorporate business objectives and optimize the use of resources.
• Problem-Solving: Lead discussions and ideation to identify, analyze, and solve complex problems related to chemical processes and plant operations. Includes investigations.
• Technical Writing & Communication: The ability to explain technical concepts clearly and accurately to technical and non-technical audiences.
• Attention to Detail: Be meticulous and pay close attention to detail to ensure accuracy and quality. Review documents and the work of others.
• Adaptability: Adapt to changing priorities, new technologies, and unexpected challenges is important. Assist others with change management.
• Project Management, Leadership, & Mentoring: Manage one’s own assignments, delegate, and support others. Manage projects, including timelines, resources, and budgets. Lead teams and mentor junior engineers. Ensure all projects meet the assigned deadlines.

Education, Experience & Licensing Requirements

• B.S. degree in Chemical Engineering or related field.
• 7-15 years of experience in chemical development, chemical manufacturing, chemical engineering design, or the equivalent.
• Experience in a chemical manufacturing environment, particularly pharmaceutical, is preferred.