Job: Process Control Engineer, Medicago USA, Durham, NC
Under the supervision of MS&T management, the candidate is responsible for the execution of activities supporting biopharmaceutical production and process monitoring. Responsibilities involve supporting process monitoring, improvement, troubleshooting, technology transfers, and validation.
• Collect, analyze, and report data to support process monitoring and trending activities, including trend analysis, to assess process performance and ensure a state of process control.
• Establish and maintain data repositories to support the development and implementation of process monitoring tools.
• Use scientific and statistical knowledge to analyze data to identify root causes of production and process events, support development and manufacturing, and drive continuous improvement activities
• Perform technology transfer activities including coordination and review of process information and documentation from development and manufacturing groups.
• Execution of fit for purpose process and system risk assessments at various stages of the product life cycle.
• Implement continuous improvement initiatives to improve process yield, reliability, and robustness.
• Provide technical support to enhance process understanding and facilitate knowledge-based decision making.
• Provide support for the generation, investigation, and resolution of process deviations and change controls for the Industrial Process Group.
• Contribute to validation, annual product review, and product quality review activities.
• Author technical documents for development, manufacturing, validation, technology transfer, and process optimization/improvement activities.
• Contribute to design and execution of process troubleshooting, scale-up, and optimization experiments using small-scale production and lab processes.
• Minimal travel to the company R&I facility in Quebec is required.
• Experience and knowledge of data management tools and statistical analysis
• Familiar with data trending and analysis. Capable of working on complex problems in development and production settings.
• Familiar with risk management tools and approaches
• Familiar with cGMP compliant production systems and documentation practices.
• Process development or operational experience with two or more of the following operations: fermentation, centrifugation, depth filtration, chromatography, tangential flow filtration.
• Able to collaborate with colleagues outside immediate department to meet development or production timelines. Builds internal networks to facilitate information sharing and teamwork.
• Familiar with QbD principles and experimental design
• Strong communication skills and attention to detail
• Performs duties in a professional and timely manner to meet timelines, costs, and cGMP requirements
• Bachelor’s degree with a minimum of 8 years' experience. Engineering degree preferred.