MilliporeSigma is seeking a Process Engineering Manager to identify, develop, and execute process improvement projects and initiatives that enhance operational efficiency and product quality.
Requirements
- Subject matter proficiency across a range of processing techniques such as filtration/ultrafiltration, and chromatography employed in the isolation and purification of blood proteins.
- Expertise and demonstrated experience in biologics process development, scale up and technical transfer.
- Expertise in design of experiments, data analysis and data interpretation for process development studies.
- Technical problem-solving ability utilizing current research and technologies.
- Previous experience with Process Analytical Technology is preferred.
- Experience with biologics manufacturing or cGMP manufacturing.
- Experience with ISO 9001, cGMP, safety and environmental legislation
Responsibilities
- Identify, develop, and execute process improvement projects and initiatives, including methods, tools, roadmap systems, and deployment.
- Manage the setup and operation of the process development laboratory.
- Provide subject matter expertise for production processes, assimilating and utilizing new technologies quickly while offering guidance, training, and direction on technical items.
- Design and lead the selection of process trains and process flows.
- Design and execute experiments to enhance process/product understanding and manufacture GMP batches at various scales.
- Create, manage, and control systems and procedures, including batch records, change controls, and standard operating procedures, with a strong focus on lean manufacturing, process efficiency, and continuous improvement.
- Lead process development activities focused on developing well-understood, science-driven products and processes at all scales, ensuring robust and repeatable control.
Other
- Bachelor’s degree in engineering/scientific discipline, or related field.
- 5+ Years experience in biologics manufacturing or cGMP manufacturing.
- 5+ Years of personnel management experience.
- Demonstrated collaborative leadership, strong people skills, and excellent verbal and written communication skills.
- Demonstrated ability to work successfully in a team/matrix environment as well as independently manage priorities and maintain timelines for multiple activities.
