Maintenance Technician

• Industry Pharma/Biotech/Clinical Research
• Work Experience 1-3 years
• City Carlow
• State/Province Carlow
• Country Ireland

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 troubleshootingall process manufacturing equipment and devices, including calibration ofinstrumentation, mechanical maintenance of high-speed filling and inspectionequipment and maintenance of control systems in support of vaccinemanufacturing.

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

Requirements

Role Functions:

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

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

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

· Support maintenance planning and preventativemaintenance through completion of planned and emergency work orders,calibrations, PMs etc.Documentmaintenance work, including upgrades, made to existing equipment, includingpreventative maintenance performed and parts used, to ensure appropriatedocumentation and records of repair history on the Computerised MaintenanceManagement System (CMMS) and Computerised Calibration Management System, SAP-PMand ProCal respectively.

· Operate and monitor production supportequipment, using MES/DCS and PLC based systems, to ensure optimum equipmentuptime and target outputs, whilst facilitating continuous process improvementsusing Lean Principles.

· Operate, troubleshoot and repair complex systemswhich may include Filling and Inspection equipment, CIP Skids, Autoclaves,Glassware Washers, production vessels, HVAC and Grade A isolators under minimalsupervision in a highly regulated, cGMP environment. Interpret P&ID’s,equipment/system layouts, wiring diagrams, and specifications in planning andperforming maintenance and repairs.

· Support continuous improvement by leading andthrough active participation in repairs, upgrades, preventative maintenance andsystem failure investigations and investigation reports.

· Execution/development of change control, andcontribution to Kaizen events as appropriate.

· Perform root cause analysis (RCA) of systemfailures and substandard equipment performance, using standard tools andmethods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5why’s etc.

· Implement subsequent corrective action throughthe change management system.

· Supply information and technical data forsecuring spare parts and equipment asset entry into the CMMS. Liaise directlywith vendors on supply of parts, upgrades to systems etc as necessary.

· Assist in general facility up keep and providesresponsive customer support with emphasis on customer satisfaction.

· Participate effectively in writing/revising/rolling out accurate operational procedures, training materials and maintenanceprocedures for various IPT systems ensuring all work is carried out in linewith same.

· Required to comply with client’s procedures andguidelines, all regulatory requirements and execute current Good ManufacturingPractices (cGMP) in the performance of day to day activities and all applicablejob functions.

· Work collaboratively to drive a safe andcompliant culture.

· May be required to perform other duties asassigned.

Experience, Knowledge & Skills:

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

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

Qualifications & Education:

· Candidates must hold a minimum of an AdvancedLevel 6 Certificate (Time Served Apprenticeship) in one of the followingdisciplines:

· Mechanical (eg. MAMF).

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