Mechanical Technician

Job Description
About PSC Biotech

Who we are?
PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

‘Take your Career to a new Level’

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

Employee Value Proposition
Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.

Job Description:

Reporting into the Maintenance Lead the Mechanical Technician will be responsible for maintaining and troubleshooting process devices, instrumentation, and controls in support of vaccine manufacturing. You will ensure that objectives are effectively achieved, consistent with company requirements to ensure compliance, safety, and reliable supply to our customers.

Requirements

Responsibilities:

·        Provide effective technical support to Production in all aspects of machine and equipment maintenance, installation, and modification; perform detailed maintenance, calibrations, PMs and troubleshooting.  (MAMF Qualified)

·        Required to operate and clean the process equipment as necessary.

·        Maintain process and production equipment, ensuring ongoing preventative maintenance, equipment troubleshooting and repairs to ensure continuous, reliable and repeatable operation of all equipment; drive Total Productive Maintenance.

·        Ensure effective management and equipment shutdown scheduling, ensuring resources are available, thereby minimizing downtown.

·        Support maintenance planning and preventative maintenance through completion of planned and emergency work orders, calibrations, PMs etc.

·        Document maintenance work, including upgrades, made to existing equipment, including preventative maintenance performed and parts used, to ensure appropriate documentation and records of repair history.

·        Operate and monitor production support equipment, using MES/DCS and PLC based systems, to ensure optimum equipment uptime and target outputs, whilst facilitating continuous process improvements using Lean Principles.

·        Operate, troubleshoot, and repair complex systems which may include Autoclaves, Glassware Washers, Single use mixers, HVAC, Isolators, filling line and inspection lines under minimal supervision in a highly regulated, cGMP environment.

·        Interpret P&ID’s, equipment/system layouts, wiring diagrams, and specifications in planning and performing maintenance and repairs.

·        Support continuous improvement by leading and active participation in repairs, upgrades, preventative maintenance and system failure investigations and investigation reports, execution/development of change control, and contribution to Kaizen events as appropriate.

·        Perform root cause analysis of system failures, substandard equipment performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.; implement subsequent corrective action through the change management system.

·        Supply information and technical data for securing spare parts and equipment asset entry into the CMMS; liaise directly with vendors on supply of parts, upgrades to systems etc as necessary.

·        Assist in general facility upkeep and provides responsive customer support with emphasis on customer satisfaction.

·        Participate effectively in writing/revising/ rolling out accurate operational procedures, training materials and maintenance procedures for various IPT systems; ensure all work is carried out in line with same.

·        Required to comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current good manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.

·        Work collaboratively to drive a safe and compliant culture.

·        May be required to perform other duties as assigned.

 

What skills you will need:

·        Time serviced MAMF Apprenticeship or equivalent Certificate/Diploma in an Engineering or related discipline is required.

·        Prior experience in a good manufacturing Practices (cGMP) and regulated pharmaceutical production environment is essential.

·        Extensive hands-on experience of preventive/reactive maintenance.

·        Understanding of mechanical/electrical/Instrumentation / pneumatic processes.

·        Proficiency in Microsoft Office and job-related computer applications required, with excellent communication skills on technical subjects.

#LI-PM3

Requirements
Responsibilities: · Provide effective technical support to Production in all aspects of machine and equipment maintenance, installation, and modification; perform detailed maintenance, calibrations, PMs and troubleshooting. (MAMF Qualified) · Required to operate and clean the process equipment as necessary. · Maintain process and production equipment, ensuring ongoing preventative maintenance, equipment troubleshooting and repairs to ensure continuous, reliable and repeatable operation of all equipment; drive Total Productive Maintenance. · Ensure effective management and equipment shutdown scheduling, ensuring resources are available, thereby minimizing downtown. · Support maintenance planning and preventative maintenance through completion of planned and emergency work orders, calibrations, PMs etc. · Document maintenance work, including upgrades, made to existing equipment, including preventative maintenance performed and parts used, to ensure appropriate documentation and records of repair history. · Operate and monitor production support equipment, using MES/DCS and PLC based systems, to ensure optimum equipment uptime and target outputs, whilst facilitating continuous process improvements using Lean Principles. · Operate, troubleshoot, and repair complex systems which may include Autoclaves, Glassware Washers, Single use mixers, HVAC, Isolators, filling line and inspection lines under minimal supervision in a highly regulated, cGMP environment. · Interpret P&ID’s, equipment/system layouts, wiring diagrams, and specifications in planning and performing maintenance and repairs. · Support continuous improvement by leading and active participation in repairs, upgrades, preventative maintenance and system failure investigations and investigation reports, execution/development of change control, and contribution to Kaizen events as appropriate. · Perform root cause analysis of system failures, substandard equipment performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.; implement subsequent corrective action through the change management system. · Supply information and technical data for securing spare parts and equipment asset entry into the CMMS; liaise directly with vendors on supply of parts, upgrades to systems etc as necessary. · Assist in general facility upkeep and provides responsive customer support with emphasis on customer satisfaction. · Participate effectively in writing/revising/ rolling out accurate operational procedures, training materials and maintenance procedures for various IPT systems; ensure all work is carried out in line with same. · Required to comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current good manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions. · Work collaboratively to drive a safe and compliant culture. · May be required to perform other duties as assigned. What skills you will need: · Time serviced MAMF Apprenticeship or equivalent Certificate/Diploma in an Engineering or related discipline is required. · Prior experience in a good manufacturing Practices (cGMP) and regulated pharmaceutical production environment is essential. · Extensive hands-on experience of preventive/reactive maintenance. · Understanding of mechanical/electrical/Instrumentation / pneumatic processes. · Proficiency in Microsoft Office and job-related computer applications required, with excellent communication skills on technical subjects.

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