About PSC Biotech
PSC Biotech is a leading biotechnology consultancy firm founded in 1996. We are headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US.
We provide cloud-based software solutions for quality management and regulatory inspections, pharmaceutical contract manufacturing professionals, and metrology services to our clients.
Our team offers a permanent contract of employment giving exposure to working in top pharmaceutical client sites in a diverse cultural work setting.
Job Description
The Mechanical Technician will be responsible for maintaining and troubleshooting process devices, instrumentation, and controls in support of vaccine manufacturing.
You will ensure that objectives are effectively achieved, consistent with company requirements to ensure compliance, safety, and reliable supply to our customers.
Responsibilities:
1. Provide effective technical support to production in all aspects of machine and equipment maintenance, installation, and modification.
2. Operate and clean the process equipment as necessary.
3. Maintain process and production equipment, ensuring ongoing preventative maintenance, equipment troubleshooting, and repairs.
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.
7. Operate and monitor production support equipment, using MES/DCS and PLC based systems, to ensure optimum equipment uptime and target outputs.
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.
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.
11. Perform root cause analysis of system failures, substandard equipment performance, using standard tools and methods, to resolve machine and system issues.
12. Supply information and technical data for securing spare parts and equipment asset entry into the CMMS.
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.
15. 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.
Requirements:
* Time-served MAMF Apprenticeship or equivalent Certificate/Diploma in an Engineering or related discipline is required.
* Prior experience in a good manufacturing practices (cGMP) and regulated pharmaceutical production environment is essential.
* Extensive hands-on experience of preventive/reactive maintenance.
* Understanding of mechanical/electrical/instrumentation/pneumatic processes.
* Proficiency in Microsoft Office and job-related computer applications required, with excellent communication skills on technical subjects.