Manufacturing Engineer III

Key Responsibilities

• Supports the design, modification, administration, and maintenance of the electronic computerized maintenance management system (ECMMS) and associated asset management processes.
• Performs ECMMS administration, data processing, process improvement, and data validation activities to support effective maintenance and asset management.
• Maintains and improves engineering systems and processes that support equipment performance and run time.
• Independently investigates and resolves manufacturing engineering issues of complex scope.
• Independently manages assigned engineering and system improvement projects through completion, including planning, execution, and tracking of project activities.
• Participates in cross-functional project teams and coordinates with Manufacturing, Packaging, Maintenance, Engineering, and other functions to resolve equipment, system, and operational issues.
• Generates, reviews, and maintains required engineering documentation supporting ECMMS, asset management, engineering activities, and system improvements.
• Supports continuous improvement initiatives to enhance engineering, maintenance, and asset management processes.
• Compiles, monitors, and reports technical performance metrics supporting engineering and maintenance activities.
• Develops and supports spare parts inventory management strategies aligned with asset management requirements.
• Oversees spare parts and critical component inventory management and storeroom operations to support maintenance activities, including inventory control, procurement, and vendor management.
• Applies engineering and reliability concepts, including equipment performance, Overall Equipment Effectiveness (OEE), Mean Time Between Failures (MTBF), and root cause failure analysis, as applicable to assigned responsibilities.
• Supports activities in accordance with current Good Manufacturing Practices (GMP) and applicable safety requirements.

Leadership & Project Responsibilities

• Act as a mentor to junior staff and provide task leadership on assigned projects.
• Lead or support cross-functional project teams and serve as a project lead within the engineering function.
• Exercise independent judgment in developing engineering solutions and making technical recommendations.
• Support strategic decisions by evaluating technical, operational, and business impacts of proposed changes.

Basic Qualifications

• Bachelor's degree in Mechanical Engineering, Chemical Engineering, Industrial Engineering, Electrical Engineering, or a related engineering discipline.
• At least 5 years of relevant engineering experience with a Bachelor's degree; or at least 3 years of relevant engineering experience with a Master's degree.
• Experience in biotechnology, pharmaceutical, life sciences, or other highly regulated manufacturing environments preferred.

Preferred Qualifications

• Experience with Root Cause Analysis (RCA), Reliability Engineering, Change Control, and CAPA.
• Lean Manufacturing, Six Sigma, or continuous improvement experience.
• Knowledge of GMP-regulated production environments and manufacturing process optimization.

Knowledge, Skills, and Abilities

• Demonstrates strong understanding and application of engineering principles, concepts, practices, and industry standards.
• Working knowledge of aseptic processes, process controls, equipment design, and manufacturing systems.
• Ability to solve semi-complex to complex technical problems through data analysis and structured problem-solving methodologies.
• Strong project management and organizational skills.
• Excellent verbal, written, and interpersonal communication skills.
• Proficiency in Microsoft Office and engineering software tools.
• Demonstrated ability to collaborate effectively across engineering, operations, quality, validation, maintenance, and supply chain functions.