Process Engineer III

As a Process Engineer III at Katalyst Healthcares & Life Sciences, your main responsibilities will include developing technical knowledge on manufacturing equipment, supporting major equipment breakdowns, providing SME support to other departments, and conducting technical analyses. You'll be involved in planning plant project execution and authoring commissioning protocols to ensure efficient operation.

To qualify for the Process Engineer III position at Katalyst Healthcares & Life Sciences, candidates should hold at least a B.S. degree in Chemical or Mechanical Engineering. Additionally, 3 to 7 years of experience in manufacturing, process engineering, or equipment support is essential for success in this role.

A Process Engineer III at Katalyst plays a key role in supporting improvement projects by planning and executing necessary changes to manufacturing equipment and processes, ensuring compliance with SOPs, and leading troubleshooting efforts. This proactive approach helps enhance both productivity and safety in our clinical research environment.

Beneficial skills for a Process Engineer III at Katalyst include strong analytical abilities, excellent problem-solving skills, effective communication, and proficiency in conducting detailed technical analyses. A keen understanding of manufacturing processes and equipment support also significantly contributes to success in this position.

At Katalyst Healthcares & Life Sciences, a Process Engineer III will handle a variety of projects including equipment changes, process improvements, and troubleshooting initiatives. Projects may involve significant CAPEX support and the implementation of design changes driven by new customer requirements.

Provide specific examples of equipment issues you resolved, detailing the methods you used to analyze and fix the problems. Highlight your approach to identifying root causes and implementing lasting solutions.

Explain your approach towards project management, utilizing tools or methodologies such as Agile or Lean. Discuss how you set priorities based on project timelines and importance.

Outline the steps you would take, including initial assessment, gathering requirements, outlining objectives, and collaborating with relevant teams. Highlight your attention to detail and adherence to regulatory standards.

Discuss your commitment to ongoing learning through industry publications, webinars, and professional organizations. Mention how staying current enhances your ability to contribute effectively to your role.

Share specific instances where you developed or revised SOPs. Include your process for ensuring comprehensive reviews and stakeholder input for maintaining compliance and efficiency.

Provide an example demonstrating your role in the change process, how you gathered support, and the impact the change had on operations. Emphasize your analytical and negotiation skills.

List the software tools or systems you've used, explaining how they’ve helped you track changes and project progress effectively. If possible, relate this to specific outcomes in previous roles.

Explain your involvement in Corrective and Preventive Actions (CAPA), focusing on how you identified issues, contributed to solutions, and monitored effectiveness post-implementation.

Discuss your understanding of relevant regulations such as FDA requirements or ISO standards and how you incorporate these into your engineering practices and documentation.

Share your views on the importance of collaboration among cross-functional teams in achieving project goals. Provide examples of successful teamwork experiences and how they contributed to project success.