What are the responsibilities and job description for the Process Engineer - Biopharma position at Mantell Associates?
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 optimise processes, including upstream and downstream operations
Conduct process simulations, modelling, 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 Optimisation and Troubleshooting:
Continuously evaluate and optimise 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 characterisation, 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 optimisation 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 modelling 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 optimisation
Excellent problem-solving skills and the ability to apply scientific principles to troubleshoot process-related issues
Strong organisational 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
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.
