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