Job Title
Mechanical Technician
We are seeking a highly skilled Mechanical Technician to join our team at PSC Biotech.
About Us
PSC Biotech is a leading biotechnology consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US.
We serve over 350 clients in more than 23 countries worldwide, providing cloud-based software solutions for quality management and regulatory inspections, pharmaceutical contract manufacturing professionals, and metrology services.
Employee Value Proposition
Our employees are the heartbeat of PSC Biotech. We offer unparalleled career development through in-house training, mentorship, and guidance to facilitate career progression.
We believe in creating high-performing teams that can exceed client expectations regarding quality, scalability, and business unit deliverables, while staying within budget and meeting timelines.
Responsibilities
1. Provide technical support to production in machine and equipment maintenance, installation, and modification, perform detailed maintenance, calibrations, PMs, and troubleshooting (MAMF Qualified)
2. Operate and clean process equipment as necessary
3. Maintain process and production equipment, ensuring ongoing preventative maintenance, equipment troubleshooting, and repairs to ensure continuous reliable operation of all equipment; drive Total Productive Maintenance
4. Ensure effective management and equipment shutdown scheduling, ensuring resources are available, thereby minimizing downtime
5. Support maintenance planning and preventative maintenance through completion of planned and emergency work orders, calibrations, PMs etc.
6. 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
7. 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
8. 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
9. Interpret P&ID's, equipment/system layouts, wiring diagrams, and specifications in planning and performing maintenance and repairs
10. 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
11. 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
12. 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
13. Assist in general facility upkeep and provide responsive customer support with emphasis on customer satisfaction
14. 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
15. 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
16. Work collaboratively to drive a safe and compliant culture
17. May be required to perform other duties as assigned
Requirements
1. Time-serviced MAMF Apprenticeship or equivalent Certificate/Diploma in an Engineering or related discipline is required
2. Prior experience in a good manufacturing Practices (cGMP) and regulated pharmaceutical production environment is essential
3. Extensive hands-on experience of preventive/reactive maintenance
4. Understanding of mechanical/electrical/Instrumentation/pneumatic processes
5. Proficiency in Microsoft Office and job-related computer applications required, with excellent communication skills on technical subjects