Equipment Engineer

The Equipment Engineer will play a critical role in the design,development, installation, and maintenance of manufacturing equipment. The EquipmentEngineer should have a strong background in engineering, equipment design, andproject management, with a focus on ensuring equipment reliability, efficiency,and compliance with regulatory standards.

Primary Responsibilities

Safety

• Ensure that all equipment designs and modifications prioritize safety and comply with relevant regulatory requirements, including FDA regulations and ISO standards.
• Conduct risk assessments and implement safety protocols to minimize hazards and ensure a safe working environment.

Quality

• Maintain equipment systems with a focus on achieving high-quality standards, implementing quality control measures, and ensuring compliance with Good Manufacturing Practices (GMP).
• Ensure that all equipment designs, modifications, and installations comply with relevant regulatory requirements, including FDA regulations, ISO standards, and Good Manufacturing Practices (GMP).
• Collaborate with Quality teams to validate equipment performance and conduct qualification activities (IQ/OQ/PQ).

Equipment Design and Development:

• Monitor manufacturing equipment and systems for packaging medical devices, ensuring adherence to specifications, quality standards, and regulatory requirements.
• Collaborate with cross-functional teams, including Quality and Production, to understand equipment requirements and develop customized solutions.
• Manage the installation, setup, and commissioning of new equipment, ensuring proper functionality, safety, and compliance with regulatory standards.
• Conduct equipment qualification activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Develop and implement preventive maintenance programs for manufacturing equipment to ensure optimal performance and uptime.
• Troubleshoot equipment issues, identify root causes, and implement corrective actions to minimize downtime and ensure continuous operation.
• Continuously evaluate equipment performance and identify opportunities for process optimization, efficiency improvement, and cost reduction.
• Implement upgrades, modifications, and enhancements to existing equipment to improve reliability, throughput, and quality.
• Collaborate with vendors and suppliers to obtain technical support, spare parts, and service contracts as needed.

Documentation and Reporting:

• Maintain accurate documentation of equipment specifications, drawings, manuals, and maintenance records.
• Prepare reports and documentation for equipment qualification, validation, and regulatory submissions.

Leadership and Team Management:

• Lead a team of technicians, providing guidance, training, and support to ensure effective equipment operation and maintenance.
• Foster a culture of safety, quality, and continuous improvement among the technician team.

Education:

• Bachelor's Degree in Mechanical, Manufacturing or Industrial Engineering, Printing Technology or closely related field.

Experience:

• Minimum 3 to 5 years’ experience in closely related function, preferably in the packaging industry.

Other Requirements:

• Strong technical skills in equipment design, automation, and control systems.
• Proficiency in CAD software for equipment design and modeling.
• Experience with equipment qualification and validation processes (IQ/OQ/PQ).
• Knowledge of regulatory requirements, including FDA regulations and ISO standards.
• Excellent problem-solving and troubleshooting abilities.
• Strong project management skills with the ability to manage multiple projects simultaneously.
• Effective communication skills and ability to collaborate with cross-functional teams.
• Attention to detail and commitment to quality and compliance.