Maintenance Technician

Found in: Talent IE C2 - 2 weeks ago

Carlow, Ireland PSC Biotech Ltd Full time
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.

Role Description:

·        Responsible for maintaining and troubleshooting all process manufacturing equipment and devices, including calibration of instrumentation, mechanical maintenance of high-speed filling and inspection equipment and maintenance of control systems in support of vaccine manufacturing.

·        The successful candidate will ensure that their objectives are effectively achieved, consistent with client’s requirements to ensure compliance, safety and reliable supply to our customers.



Requirements

Role Functions:

·        Provide effective technical support to the production value streams in all aspects of machine and equipment maintenance, installation and modification.

·        Perform detailed maintenance, calibrations, PMs and troubleshooting. Required to operate and clean the process equipment during troubleshooting and post interventions as necessary.

·        Maintain process and production equipment, ensuring ongoing preventative maintenance, equipment troubleshooting, and repairs are completed in a timely manner to ensure continuous, reliable and repeatable operation of all equipment in line with client Production Systems (MPS).

·        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 on the Computerised Maintenance Management System (CMMS) and Computerised Calibration Management System, SAP-PM and ProCal respectively.

·        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 Filling and Inspection equipment, CIP Skids, Autoclaves, Glassware Washers, production vessels, HVAC and Grade A isolators 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 through 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 (RCA) of system failures and 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 up keep 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 ensuring all work is carried out in line with same.

·        Required to comply with client’s procedures and guidelines, all 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.

 

Experience, Knowledge & Skills:

·        Candidates must have prior related work experience; ideally in a manufacturing, GMP setting.

·        A minimum 2 + Years in a maintenance and repair role within the Pharmaceutical Industry is preferred. Candidates with sterile fill finish, component preparation (i.e. Autoclaves, Washers, CIP skids) and high-speed inspection maintenance experience are desirable. 

 

Qualifications & Education:

 

·        Candidates must hold a minimum of an Advanced Level 6 Certificate (Time Served Apprenticeship) in one of the following disciplines:

·        Mechanical (eg. MAMF).

·        Electrical or Electrical/Instrumentation (E/I).



Requirements
Role Functions: · Provide effective technical support to the production value streams in all aspects of machine and equipment maintenance, installation and modification. · Perform detailed maintenance, calibrations, PMs and troubleshooting. Required to operate and clean the process equipment during troubleshooting and post interventions as necessary. · Maintain process and production equipment, ensuring ongoing preventative maintenance, equipment troubleshooting, and repairs are completed in a timely manner to ensure continuous, reliable and repeatable operation of all equipment in line with client Production Systems (MPS). · 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 on the Computerised Maintenance Management System (CMMS) and Computerised Calibration Management System, SAP-PM and ProCal respectively. · 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 Filling and Inspection equipment, CIP Skids, Autoclaves, Glassware Washers, production vessels, HVAC and Grade A isolators 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 through 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 (RCA) of system failures and 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 up keep 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 ensuring all work is carried out in line with same. · Required to comply with client’s procedures and guidelines, all 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. Experience, Knowledge & Skills: · Candidates must have prior related work experience; ideally in a manufacturing, GMP setting. · A minimum 2 + Years in a maintenance and repair role within the Pharmaceutical Industry is preferred. Candidates with sterile fill finish, component preparation (i.e. Autoclaves, Washers, CIP skids) and high-speed inspection maintenance experience are desirable. Qualifications & Education: · Candidates must hold a minimum of an Advanced Level 6 Certificate (Time Served Apprenticeship) in one of the following disciplines: · Mechanical (eg. MAMF). · Electrical or Electrical/Instrumentation (E/I).

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