Job Description
About PSC Biotech
Who are we?
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 Employee Value Proposition as one of our unique selling points, 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, providing exposure to top pharmaceutical client sites in a diverse cultural work setting.
Employee Value Proposition
Employees are the “heartbeat” of PSC Biotech. We provide unparalleled career development through in-house training, mentorship, and constant guidance to facilitate career progression. We aim to create high-performing teams that exceed our client’s expectations regarding quality, staying under budget, and meeting project timelines.
Overview:
The Mechanical Technician will be responsible for maintaining and troubleshooting process devices, instrumentation, and controls in support of vaccine manufacturing. You will ensure objectives are achieved effectively, in compliance with company requirements to ensure safety and reliable supply to our customers.
Reporting to: Maintenance Lead
Shift Pattern: Days initially, moving to 2-cycle shifts (7 am-3 pm, 3 pm-11 pm)
Requirements
Responsibilities:
* Provide effective technical support to Production in all aspects of machine and equipment maintenance, installation, and modification; perform detailed maintenance, calibrations, PMs, and troubleshooting. (MAMF Qualified)
* Operate and clean process equipment as necessary.
* Maintain process and production equipment, ensuring ongoing preventative maintenance, troubleshooting, and repairs for continuous, reliable operation; drive Total Productive Maintenance.
* Manage equipment shutdown scheduling, ensuring resource availability to minimize downtime.
* Support maintenance planning and preventive maintenance through completion of work orders, calibrations, and PMs.
* Document maintenance work, upgrades, and parts used to ensure proper records of repair history.
* Operate and monitor production support equipment using MES/DCS and PLC systems to ensure optimal uptime and outputs, and facilitate continuous process improvements using Lean principles.
* Operate, troubleshoot, and repair complex systems including autoclaves, glassware washers, single-use mixers, HVAC, isolators, filling lines, and inspection lines under minimal supervision in a cGMP environment.
* Interpret P&ID’s, equipment layouts, wiring diagrams, and specifications for maintenance and repairs.
* Support continuous improvement initiatives, including repairs, upgrades, system failure investigations, change control, and Kaizen events.
* Perform root cause analysis of system failures using tools like FMEA, Fishbone diagrams, and 5 Whys; implement corrective actions through change management.
* Provide technical data for spare parts and asset entry into CMMS; liaise with vendors for parts and system upgrades.
* Assist in facility upkeep and provide responsive customer support.
* Participate in writing, revising, and implementing operational procedures, training materials, and maintenance procedures.
* Ensure compliance with global policies, procedures, regulatory requirements, and cGMP standards.
* Promote a safe and compliant work culture.
* Perform other duties as assigned.
Skills Required:
* Serviced MAMF Apprenticeship or equivalent Certificate/Diploma in Engineering or related discipline.
* Prior experience in a cGMP-regulated pharmaceutical environment.
* Extensive hands-on experience in preventive/reactive maintenance.
* Understanding of mechanical, electrical, instrumentation, and pneumatic processes.
* Proficiency in Microsoft Office and other job-related applications, with excellent technical communication skills.
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