Process Engineer

Summary

The Process Engineer is responsible for designing, implementing, maintaining, and improving all regional sterilization processes, process data gathering, and maintenance document control processes as needed. They also identify and implement process related improvement activities to reduce and minimize non-conformances and events.

Essential Duties and Responsibilities

• Maintain and improve the sterilization process system along with measuring and tracking facilities department KPIs.
• Responsible for process system activities for all sterilization processes to maximize process capability on equipment performance.
• Identify areas of process improvement (including safety related improvements and labor efficiency related process improvements) to reduce and minimize process related nonconformance incidents and to maximize efficiency of the process.
• Improve processes to ensure that all equipment uptime is tracked and measured along with monitoring and measuring sterilization OEE.
• Provide informative process performance reports and trend analysis to management through data analysis tools and other techniques. Train technicians on the usage of systems as needed.
• Initiate, plan, execute, and close out projects as assigned and assist QA in disposition of equipment/process non-conformances, including documentation of corrective actions and/or acceptance rationale and Engineering comments.
• Available for “Engineering on call” activities in the future.

Qualifications

• Bachelor's of Science Degree in Engineering required. 5+ years of applicable experience and a thorough understanding of a wide variety of engineering systems. Experience in FDA regulated manufacturing environment and implementing, developing, and maintaining process/projects is preferred. PSM-related industry experience is a plus. CAD experience is preferred.
• Must be able to read and comprehend simple instructions in Basic English and write short correspondence/memos. Must be able to effectively present information in one-on-one and small group situations to staff, internal customers, and other employees within the organization.
• Ability to apply mathematical concepts such as geometry, trigonometry, exponents, etc. Ability to apply mathematical operations to tasks such as facility design, process line location and layout.
• Good logic and reasoning ability. Ability to define problems and find logical solutions. Ability to interpret specifications and technical instructions. High degree of logical analyzing is required. Errors in facility or process design bring heavy liability and financial burden to the Company. Errors in safety equipment could bring loss of life. Interfaces heavily with outside personnel.

Physical Demands

• Regularly use hands to finger, handle or feel.
• Occasionally lift and/or move up to ten pounds.
• Stand and reach with hands and arms.
• Work with moving mechanical parts, high places, risk of electrical shock, work with explosive gas, toxic and caustic chemicals, or experience loud noise (maintenance shop, forklift equipment, and construction).