We are seeking a Project Engineer to support equipment and process improvement projects within a regulated manufacturing environment.
Key Responsibilities

• Manage small to medium-sized engineering projects from concept through implementation.
• Define equipment requirements and develop User Requirement Specifications (URS).
• Support equipment selection, supplier engagement, and project execution.
• Assist with project planning, budgeting, and stakeholder coordination.
• Lead or support equipment qualification and validation activities (IQ/OQ/PQ).
• Investigate equipment issues, identify root causes, and implement corrective actions.
• Drive continuous improvement initiatives focused on safety, quality, efficiency, and reliability.
• Monitor equipment performance, downtime, and maintenance requirements.
• Work closely with operations, quality, maintenance, and external vendors to deliver successful project outcomes.

Requirements

• Degree in Engineering or a related technical discipline.
• Experience working in a manufacturing, pharmaceutical, medical device, or regulated production environment.
• Project engineering experience involving manufacturing equipment or process systems.
• Knowledge of equipment qualification, validation, and GMP requirements.
• Experience with root cause analysis, CAPA, and continuous improvement methodologies.
• Strong communication and stakeholder management skills.

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