I & E Technician
This position will maintain systems and equipment within the Aseptic production process. The technician is responsible for supporting the Aseptic Production Process by performing electrical and instrumentation maintenance on all equipment with a high quality mindset, safely and within a defined schedule. The technician will perform maintenance and calibrations on equipment and components related to compressed air, electromechanical, controls, electrical, mechanical, instrumentation and robotics. Additionally, the mechanic will be responsible for documenting all actions in equipment logs and a computerized maintenance management system.
- Perform 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.
- Ensure that the Aseptic production equipment is maintained to an appropriate standard in line with current pharmaceutical regulatory requirements, industry standards, government regulations and requirements as well the 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 production process.
- Work on all 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.
- Utilizing standard test equipment, test fixtures, software, and hand tools, perform routine and moderately complex functional tests, calibration, and performance verification to instruments and prescribed assemblies.
- Completes and documents, 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.
- Personnel engaged in the manufacturer, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings shall be worn as necessary to protect drug products from contamination.
- 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.
- Ability to understand, and work with, regulatory requirements such as 21CFR part 210 and 211, CGMP’s, FDA, OSHA and other regulatory agencies.
- Demonstrated ability to read, comprehend and interpret equipment manuals, mechanical and electrical drawings and schematics and PLC logic.
- Ability to read, comprehend and execute Standard Operating Procedures (SOP) and instruction documents.
- Knowledge of CMMS programs and current regulatory requirements regarding Environmental Health & Safety.
- Experience in pharmaceutical electrical maintenance with Aseptic or Injectable experience preferred.
Xellia Pharmaceuticals is owned by Novo Holding A/S and is a specialty pharmaceutical company leading in the development, manufacture and supply of anti-infective treatments. Headquartered in Copenhagen, Denmark, Xellia has global facilities in Europe, North America, and Asia, currently employing over 1700 people. With over 100 years of industry experience in developing last resort treatments for infectious diseases, Xellia is focused on the supply of products which not only save lives, but also improve and enhance patients’ quality of life. Together with us, you can help lead the fight against bacterial infections.
Read more about Xellia Pharmaceuticals