Process Engineer - Biopharma

Posted 15 May 2024
Salary Negotiable
LocationPennsylvania
Job type Full Time
Discipline Large MoleculeSmall Molecule
ReferenceBBBH1730_1715778081
Contact NameEwan Rennison

Job description

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.