This position will maintain systems and equipment within the Aseptic production process. The mechanic is responsible for supporting the Aseptic Production Process by performing maintenance on all equipment with a high quality mindset, safely and within a defined schedule. The mechanic will perform maintenance 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 maintenance assignments, to include routine maintenance, 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. Perform routine preventive maintenance in an aseptic environment on production machinery and equipment including mechanical, electro-mechanical, pneumatic, robotic and other systems.
- Complete and document, per SOP's and regulatory requirements, all corrective and routine preventive maintenance as well as scheduled performance evaluations for assigned equipment.
- Utilize a Computerized Maintenance Management System (CMMS) to document and track maintenance activities.
- 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.
- Completed apprentice/journeyman program in a maintenance related field such as machine repairman or technical vocational certificates from an accredited tech/trade school is preferred.
- Experience in pharmaceutical maintenance with Aseptic or Injectable experience 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 PLC logic.
- Ability to assemble/disassemble and repair machine components (i.e., gears, bearings, shafts, chains, sprockets, pulleys, cams, etc.). Able to use precision measuring equipment (i.e., dial calipers, micrometers, etc.).
- 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.
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.
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Production Equipment Controls
Computerized Maintenance Management Systems