We are seeking an experienced Process Engineer experienced in the life sciences industry to join our team. As a Process Engineer, you will play a key role in designing, optimizing, and overseeing processes to ensure the highest quality and efficiency in the production of multiple types of pharmaceutical products.
Responsibilities
- Collaborate with cross-functional teams to design, develop, and optimize manufacturing processes in the life sciences industry.
- Conduct process simulations, evaluate and implement process improvements, and troubleshoot operational issues.
- Participate in the development and review of process documentation, including P&IDs, standard operating procedures, and batch records.
- Ensure processes comply with industry-specific regulations and standards, such as cGMP, FDA, and other relevant guidelines.
- Provide technical expertise in areas like aseptic processing, downstream and upstream processing, filtration, sterilization, and purification techniques.
- Lead or support process validation activities to ensure product quality and regulatory compliance.
- Investigate deviations, incidents, and quality issues, and propose corrective and preventive actions.
- Collaborate in the scale-up and technology transfer of processes from development to commercial production.
- Support equipment selection, qualification, and maintenance activities.
- Keep abreast of industry trends and advancements to drive continuous improvement in processes and technologies.