Mechanical Engineer Job

Mechanical Engineer is needed to perform the following duties:

· Own and support day-to-day performance of assigned mechanical systems and equipment. Troubleshoot and resolve mechanical issues in packaging, pilot lines, or capital projects, collaborating with Operations, Maintenance, Automation, Facilities, and Quality teams.

· Lead or participate in technical investigations, perform root cause analysis, and implement corrective and preventive actions (CAPA) to minimize downtime and improve system performance.

· Assist in conceptualizing and executing capital projects—from design through commissioning. Handle documentation, vendor quotes, equipment selection, cost estimates, and schedule coordination.

· Work with cross-functional teams—Engineering, Project Management, Quality, Validation, Operations—to coordinate technical activities and deliver engineering solutions aligned with manufacturing goals.

· Investigate equipment failures using statistical and engineering tools, and implement CAPA to improve system reliability, ensuring long-term resolution.

· Use tools like SPC, predictive maintenance, and Six Sigma to analyze equipment performance. Identify optimization opportunities and support implementation of improvements.

· Manage equipment lifecycle including commissioning, maintenance planning, performance monitoring, and decommissioning to ensure uptime and regulatory compliance.

· Own and operate critical manufacturing systems, ensuring high performance and continual improvement aligned with production goals and compliance standards.

· Develop and interpret engineering specifications using CAD tools and GD&T to ensure accuracy in mechanical system design and documentation.

· Coordinate with external vendors and contractors for equipment procurement, installation, and service by communicating technical requirements and project timelines.

· Ensure mechanical system compliance with GMP, FDA, ISO, and internal safety and quality standards, supporting audits and documentation efforts.

· Troubleshoot instrumentation and mechanical interfaces using understanding of sensors, control systems, and diagnostic tools.

· Plan and execute preventive and predictive maintenance schedules based on performance data, ensuring system reliability and reduced downtime.

· Support validation runs and equipment trials by preparing systems, monitoring parameters, and documenting output per regulatory guidelines.

· Use engineering and statistical tools to analyze mechanical system data, identify trends, and propose data-driven decisions for continuous improvement.

Bachelor's Degree is required in Mechanical Engineering.

Health/Dental Benefits, Paid Holidays, Vacations, and Sick Leave