Process Engineer - Biopharma

Mantell Associates are currently partnered with a unique biopharma organisation who are searching for a Process Engineer.

Process Engineer - Responsibilities:

• Design and Development:
• Design, develop, and optimize processes, including upstream and downstream operations
• Conduct process simulations, modeling, and scale-up studies to ensure efficient and cost-effective production
• Collaborate with cross-functional teams, such as Research and Development, Manufacturing, and Quality Assurance, to ensure seamless process integration
• Process Optimization and Troubleshooting:
• Continuously evaluate and optimize processes to enhance yield, productivity, and product quality
• Identify process bottlenecks, perform root cause analysis, and implement corrective actions to improve process performance
• Troubleshoot process-related issues and provide timely solutions to ensure smooth manufacturing operations
• Technology Transfer and Scale-Up:
• Support technology transfer activities, including the transfer of processes from R&D to manufacturing
• Collaborate with internal and external stakeholders to ensure successful scale-up and implementation of new processes
• Provide technical expertise during process validation activities, including process characterization, qualification, and validation protocols
• Documentation and Compliance:
• Generate and maintain detailed process documentation, including batch records, standard operating procedures (SOPs), and process descriptions
• Ensure compliance with cGMP regulations, safety guidelines, and relevant quality management systems
• Collaborate with the Quality Assurance team to conduct risk assessments, support investigations, and implement corrective actions
• Continuous Improvement and Innovation:
• Stay up-to-date with industry trends, new technologies, and scientific advancements
• Identify opportunities for process improvement, automation, and innovation to enhance efficiency, productivity, and product quality
• Initiate and lead process optimization projects to drive operational excellence and ensure competitiveness in the market

Bioprocess Engineer - Requirements:

• Bachelor's or Master's degree in Chemical Engineering, Biotechnology, or a related field. A Ph.D. is a plus
• Proven experience in process engineering, process development, or related roles within the biopharmaceutical industry
• Strong knowledge of processing principles, including upstream and downstream unit operations, process scale-up, and technology transfer
• Proficiency in process simulation and modeling software, such as Aspen Plus, SuperPro Designer, or similar tools
• Familiarity with cGMP regulations and quality management systems in the biopharmaceutical industry
• Experience with statistical analysis and design of experiments (DoE) for process optimization
• Excellent problem-solving skills and the ability to apply scientific principles to troubleshoot process-related issues
• Strong organizational skills, attention to detail, and the ability to manage multiple projects simultaneously
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams

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Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at +44 (0)20 3854 7700.