Process Support Technician
Xellia

Job Info

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This position will maintain systems and equipment within the Aseptic Production Process. The Maintenance Technician is responsible for supporting automation, electrical and instrumentation systems. The technician will perform maintenance and calibrations on equipment and systems such as utilities, controls, electrical, mechanical, instrumentation and robotics. The technician will serve as a resource for sharing knowledge and assisting others with understanding complex automation equipment and systems. The technician will be responsible for proper documentation in equipment logbooks and a computerized maintenance management system.

Key Responsibilities

• Perform automation, electrical and instrumentation maintenance assignments, to include routine maintenance, calibration, diagnostics, troubleshooting, repair, installation and overhaul of manufacturing / processing equipment within an Aseptic Production environment.
• Support operations by providing technical guidance and oversight on the plant floor during operations.
• Maintain electrical and electronic equipment, such as electrical components, controllers, programmable logic controllers, robots, servos, VFD's, electric motors, control panels, instrumentation device, wire, cables, printers, conduit, etc.
• Perform calibration and maintenance of critical instruments to include pressure, temperature, level, flow, control valves and devices and instrument shop equipment.
• Ensure production equipment is maintained to an appropriate standard in line with current pharmaceutical regulatory requirements, industry standards, and guidelines set by Xellia.
• Provide maintenance support to all aspects of the production efforts as established in department procedures and as required by regulatory agencies in order to ensure, and maintain, safe, CGMP compliant equipment and facilities.
• Contribute as required to maintain all production equipment maintenance within the scheduled completion dates while maintaining the validated state of the equipment and process.
• Utilize a Computerized Maintenance Management System (CMMS) to document and track maintenance activities.
• Complete and document, per SOP's and regulatory requirements, all corrective and routine preventive maintenance and scheduled performance evaluations for assigned equipment.
• Ensure that all production equipment is running optimally, both in terms of output and quality and assist operations as needed in order to meet company quality and production targets.
• Partner with Quality to ensure processes and products are in compliance with all local, state, and federal rules and regulations. Oversees that processes are in CGMP compliance, and establish systems that identifies opportunities for improvement and makes constructive suggestions for change to improve process effectiveness to heighten quality. Develop knowledge of and understand regulatory requirements such as 21 CFR Parts 210 and 211, CGMPs, FDA, OSHA and other regulatory agencies.

Qualifications

• Required: HS Diploma/GED and 3+ years applicable experience
• Technical vocational certificates or degree from an accredited tech/trade school in an electronics maintenance or automation engineering related field or equivalent experience in electrical/electronic controls is preferred.
• Experience in pharmaceutical electrical maintenance with Aseptic or Injectable experience preferred.

Xellia Pharmaceuticals is a specialty pharmaceutical company developing, manufacturing and commercializing anti-infective treatments against serious and often life-threatening bacterial and fungal infections. Headquartered in Copenhagen, Denmark, Xellia has a global footprint with R&D, manufacturing and commercial operations across Europe, Asia, the Middle East and North America. Xellia is wholly owned by Novo Holdings A/S and employs a dedicated team of over 1,800 people.
With over 115 years of experience, Xellia is a world-leading trusted supplier of several important established anti-infective drugs, comprising active pharmaceutical ingredients as well as injectable products. Continuing the Company's evolution, Xellia is generating an innovative pipeline of value-added anti-infective medicines intended to enhance patient care, providing convenience and ease of use for healthcare professionals.
Together you can help us lead the fight against infections.

Further information about Xellia can be found at: www.xellia.com
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