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.
This role will manage all equipment and system validation activities for the cGMP manufacture of biological bulk drug substances. The Qualification Engineer will provide equipment / system process engineering and validation expertise to support the facility start-up and routine commercial manufacturing.
Responsible for maintaining and troubleshooting process devices, instrumentation and controls in support of vaccine manufacturing. Ensure that objectives are effectively achieved, consistent with requirements to ensure compliance, safety and reliable supply to our customers.
Provide technical support to the business through start-up of the new manufacturing facility through development of task lists, spare part identification, attendance at FAT/SAT and support of the equipment procurement, installation, commissioning and qualification phases.
Role 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 wastewater 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, 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.
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 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 in Carlow.
May be required to perform other duties as assigned.
Requirements
Would typically have prior related work experience; ideally in a manufacturing, preferably GMP setting.
Technical
Troubleshooting and maintaining process instrumentation and equipment
Understanding of mechanical/electrical/Instrumentation / pneumatic processes
Sterile filling processes
Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
Report, standards, policy writing skills required
Proficiency in Microsoft Office and job related computer applications required
Lean 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 customers
Understand the specific responsibilities of all Carlow departments as they relate to ones own department, understanding the business processes ones department supports.
Customer service
Vendor liaison
Self-motivated
Flexible approach
Effective time management and multi-tasking skills
Excellent attention to detail
Trouble shooting skills
Goal/results orientated
Data analysis
Training skills
Leadership
Focus on Customers and Patients
Collaborate
Act with Candor and Courage
Make Rapid, Disciplined Decisions
Drive Results
Build Talent
- Demonstrate Ethics and Integrity
Leaving Certificate or equivalent required.
Time serviced Apprenticeship or equivalent Certificate/Diploma in an Engineering or related discipline is required.
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Would typically have prior related work experience; ideally in a manufacturing, preferably GMP setting. Technical Troubleshooting and maintaining process instrumentation and equipment Understanding of mechanical/electrical/Instrumentation / pneumatic processes Sterile filling processes Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices Report, standards, policy writing skills required Proficiency in Microsoft Office and job related computer applications required Lean 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 customers Understand the specific responsibilities of all Carlow departments as they relate to ones own department, understanding the business processes ones department supports. Customer service Vendor liaison Self-motivated Flexible approach Effective time management and multi-tasking skills Excellent attention to detail Trouble shooting skills Goal/results orientated Data analysis Training skills Leadership Focus on Customers and Patients Collaborate Act with Candor and Courage Make Rapid, Disciplined Decisions Drive Results Build Talent - Demonstrate Ethics and Integrity Leaving Certificate or equivalent required. Time serviced Apprenticeship or equivalent Certificate/Diploma in an Engineering or related discipline is required.