About PSC BiotechWho 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 PropositionEmployees 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 process
devices, instrumentation and controls in support of vaccine manufacturing.
Ensure that objectives are effectively achieved, consistent with client’s
requirements to ensure compliance, safety and reliable supply to our customers.RequirementsRole Functions:Provide effective technical support to Production 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 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 CIP, Autoclaves, Glassware Washers, production vessels, HVAC,
Isolators, compressed gasses, plant steam/condensate, bulk chemical
distribution and waste water treatment 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 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; ensure all work is carried out in line with same.Leadership activities including selection, development,
coaching and day to day management. Ensure that the team receives appropriate
resources and programmes to develop technical and other skills, to complete
their jobs whilst stimulating personal growth and development in line with
role. Develop and maintain training programmes.Required to comply with client 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 Experience, Knowledge & Skills:Would typically have prior related work experience; ideally
in a manufacturing, preferably GMP setting. Technical:Troubleshooting and maintaining process instrumentation and
equipmentUnderstanding of mechanical/electrical/Instrumentation /
pneumatic processesSterile filling processesKnowledge of regulatory/code requirements to Irish, European
and International Codes, Standards and PracticesReport, standards, policy writing skills requiredProficiency in Microsoft Office and job related computer
applications requiredLean Six Sigma Methodology experience desired. Business:Effective communication and interpersonal skills to
interface effectively with all levels of colleagues in a team environment, and
with external customersUnderstand the specific responsibilities of all Carlow
departments as they relate to ones own department, understanding the business
processes ones department supports.Customer serviceVendor liaisonSelf-motivatedFlexible approach Experience, Knowledge & Skills:Effective time management and multi-tasking skillsExcellent attention to detailTrouble shooting skillsGoal/results orientatedData analysisTraining skills Leadership:Focus on Customers and PatientsCollaborateAct with Candor and CourageMake Rapid, Disciplined DecisionsDrive ResultsBuild TalentDemonstrate Ethics and Integrity Qualifications & Education:Leaving Certificate or equivalent required.Time serviced Electrical / Electrical & Instrumentation
/ Mechanical Fitter / MAMF Apprenticeship is required.