Manufacturing Engineering Technologist

Job Responsibilities:

• Resolve issues that arise in the day-to-day operation of manufacturing processes, providing timely responses and effective solutions
• Collaborate with cross-functional technical teams and site leadership to implement process and equipment improvements
• Serve as a Subject Matter Expert (SME) for aseptic filling equipment and supporting manufacturing systems
• Evaluate, maintain, and improve the efficiency and reliability of manufacturing instruments, equipment, and tools
• Support the implementation of new technologies, process enhancements, and operational changes
• Participate in and support Process Failure Mode and Effects Analysis (FMEA) activities to identify and mitigate process and product risks
• Provide hands-on technical support for manufacturing activities, troubleshooting, and preventative maintenance efforts
• Apply Good Engineering Practices (GEP) to support engineering compliance and operational excellence
• Partner with vendors and suppliers to define equipment requirements and review functional specifications
• Support data integrity initiatives and implementation of digital manufacturing technologies
• Maintain ownership of manufacturing equipment tracking systems and related documentation
• Drive continuous improvement initiatives focused on quality, efficiency, and process reliability
• Mentor manufacturing personnel and encourage problem-solving and solution-driven thinking
• Support production schedules through flexible work hours when necessary to ensure facility coverage

Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or related technical field with 5+ years of relevant experience
• OR 10+ years of relevant manufacturing engineering or technical operations experience
• Experience in pharmaceutical, biologics, medical device, or other highly regulated manufacturing environments
• Knowledge of cGMP manufacturing practices and regulatory requirements
• Experience with aseptic processing, sterile manufacturing, fill-and-finish operations, and process development
• Strong understanding of process controls, instrumentation, electro-mechanical systems, and manufacturing equipment
• Ability to become a Subject Matter Expert (SME) for aseptic filling, inspection, and packaging equipment
• Lean Six Sigma certification preferred