- 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.
- 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).
- 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.
- Maintain accurate documentation of equipment specifications, drawings, manuals, and maintenance records.
- Prepare reports and documentation for equipment qualification, validation, and regulatory submissions.
- 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.
- Bachelor's Degree in Mechanical, Manufacturing or Industrial Engineering, Printing Technology or closely related field.
- Minimum 3 to 5 years' experience in closely related function, preferably in the packaging industry.
- 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.
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Engineer _ Equipment
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Equipment Engineer - Malaysia - Oliver Healthcare Packaging
5 days ago
Description
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
Quality
Equipment Design and Development:
Documentation and Reporting:
Leadership and Team Management:
Education:
Experience:
Other Requirements:
