Senior Process Engineer - API Manufacturing

Our client, a leading pharmaceutical company at the forefront of medical innovation, is seeking an exceptional Senior Process Engineer to join their fully remote engineering team. This is a unique opportunity to contribute to the development and optimization of manufacturing processes for Active Pharmaceutical Ingredients (APIs). You will leverage your expertise in chemical engineering and process design to drive efficiency, scalability, and quality in our state-of-the-art manufacturing facilities. Working remotely, you will collaborate with global teams, applying your skills to critical projects that impact patient health worldwide.

Key Responsibilities:

Design, develop, scale-up, and optimize manufacturing processes for APIs, ensuring compliance with GMP and regulatory standards. Conduct process hazard analyses (PHAs), FMEAs, and other risk assessments to ensure process safety and reliability. Develop process flow diagrams (PFDs), piping and instrumentation diagrams (P&IDs), and equipment specifications. Lead troubleshooting efforts for manufacturing process deviations and implement corrective and preventive actions (CAPAs). Collaborate with R&D, Quality Assurance, and Production teams to ensure seamless technology transfer and process validation. Develop and implement process control strategies to ensure consistent product quality and yield. Identify opportunities for process improvement, cost reduction, and efficiency gains through data analysis and technological advancements. Manage engineering projects from conception through to execution, including scope definition, budgeting, and timeline management. Stay current with industry best practices, emerging technologies, and regulatory requirements in pharmaceutical manufacturing. Mentor junior engineers and contribute to the technical development of the team. Prepare and present technical reports, project updates, and validation documentation. Ensure all engineering activities adhere to safety, environmental, and quality regulations. Participate in process design reviews and provide expert input. Evaluate and select appropriate equipment for API manufacturing processes. Optimize reaction kinetics, separation processes, and crystallization steps.

Qualifications:

Master's or PhD in Chemical Engineering or a related field. A minimum of 6 years of experience in process engineering within the pharmaceutical or fine chemical industry, with a strong focus on API manufacturing. In-depth knowledge of GMP, ICH guidelines, and regulatory requirements for pharmaceutical manufacturing. Proven experience in process design, scale-up, validation, and optimization. Strong understanding of chemical reaction engineering, thermodynamics, fluid dynamics, and mass transfer. Experience with process simulation software (e.g., Aspen Plus, HYSYS) is highly desirable. Excellent analytical, problem-solving, and project management skills. Proficiency in P&ID development and interpretation. Strong understanding of process safety principles and risk assessment methodologies. Exceptional communication, collaboration, and interpersonal skills, particularly in a remote team setting. Ability to work independently, manage multiple priorities, and meet deadlines. Experience with statistical process control (SPC) and data analysis is a plus. This role is based in **London, England, UK**, but is fully remote, offering the convenience and flexibility to work from anywhere.