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 (EVP) 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 opportunities through in-house training, mentorship, and constant guidance to facilitate career progression. We believe in creating high-performing teams that can exceed our clients’ 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 that objectives are effectively achieved, consistent with company requirements to ensure compliance, safety, and reliable supply to our customers.
Reporting to: Maintenance Lead
Shift Pattern: Days initially, moving to a 2-cycle shift pattern (7am-3pm, 3pm-11pm)
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 to ensure continuous and reliable operation; drive Total Productive Maintenance.
* Manage equipment shutdown scheduling to minimize downtime.
* Support maintenance planning and preventative maintenance through work orders, calibrations, PMs, etc.
* 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, aiming for optimal uptime and outputs, while facilitating continuous improvements using Lean principles.
* Operate, troubleshoot, and repair complex systems such as Autoclaves, Glassware Washers, Single-use mixers, HVAC, Isolators, filling lines, and inspection lines in a cGMP environment.
* Interpret P&ID diagrams, equipment layouts, wiring diagrams, and specifications for maintenance and repairs.
* Lead and participate in repairs, upgrades, preventative maintenance, 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 via change management.
* Provide technical data for spare parts and asset entry into the CMMS; liaise with vendors for parts and system upgrades.
* Assist with facility upkeep and provide responsive customer support.
* Contribute to writing, revising, and implementing operational and maintenance procedures and training materials.
* 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:
* Time-served MAMF Apprenticeship or equivalent Certificate/Diploma in Engineering or related discipline.
* Experience in a cGMP-regulated pharmaceutical environment.
* Hands-on experience in preventive/reactive maintenance.
* Understanding of mechanical, electrical, instrumentation, and pneumatic processes.
* Proficiency in Microsoft Office and related applications, with excellent technical communication skills.
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