Job Summary:

The Technician is responsible to support processes or equipment in production and throughout the manufacturing facility.

Essential Duties and Responsibilities:

Include the following:

• Work with Process and Manufacturing Engineering to develop and refine processes for production.
• Work with Development or Manufacturing on the transfer of new products to manufacturing and define process capabilities.
• Fixture development to improve throughput in manufacturing, this to include concept, refinement, evaluation, and implementation.
• Support and run experiments to evaluate process improvement ideas.
• Review and implement supporting documentation including DHR’s, MPI’s, SOP’s, & ECO’s.
• Identify training requirements and train production personnel in accordance with company, department, ISO, and GMP guidelines.
• Work “on-line” as the production schedule demands.
• Design, specify, manufacture, test and document production equipment, changes and improvements.
• Supports the scheduled and unscheduled maintenance activities to support manufacturing lines by conducting PM’s, documenting PM procedures and adhering to the PM scheduling for equipment under area of responsibility.
• Assist in conducting IQ/OQ/PQ process of equipment. Assist in the creation and maintenance of up-to-date area SOPs.
• Perform setup, troubleshooting and shut down of equipment.
• Liaise with Global IT support desk to support the resolution of IT service equipment.  
• Liaise with outside service support groups on the maintenance and installation of HVAC, Air Handling Units, and cleanroom and pressurised vessels and general electrical networks throughout the facility.
• Support Environmental Health & Safety activities. Carrying out risk assessments of equipment / processes, contributing to the EH & S committee and its execution of tasks & carrying out ergonomic studies. 
• Maintain and generate facility layout and cleanroom drawings.
• Maintain and comply with ISO13485, GMP and FDA regulations.
• Work as part of production support team to drive process improvements.
• Take responsibility for preventative maintenance procedures with an assigned process or area.

·       Interface with a variety of personnel and with outside vendors when necessary while performing the above.

·       Required to perform rotating shift duties, including evening and night shifts, and may be assigned different roles within the team to support operational needs.

·       Any other project or duties as assigned.

Education/Experience and Qualifications:

• GCE “O” level or higher with 1-3 years assembly or technician experience preferably in medical device.
• Able to work with a variety of equipment and to troubleshoot and correct mechanical/electrical problems as they arise.
• Computer literacy required.  Familiar with Microsoft office software and AutoCAD a plus.
• Knowledgeable in writing manufacturing procedures and GMP requirements.
• Knowledgeable in GMP, ISO, cleanroom procedures, and documentation.
• Good technical knowledge and understanding of broad scope of manufacturing processes.
• Excellent communication skills.
• Environmental Health & Safety Training is desired but not essential.