Would you like to join an award winning organization that is dedicated to saving lives?
In 2019, Xellia Pharmaceuticals was recognized by the Business Culture Awards as an organization that has impacted its culture through transformative initiatives. Focused on building a sustainable environment through company values and a leadership promise to its employees. Our people make us what we are. We aim to attract the most talented, passionate employees in our industry and to earn their loyalty and commitment. We support our employees through comprehensive people resources processes ensuring that every employee is treated fairly and has a voice which is listened to and valued.
Is that you? If so, we want to learn more about you!
Our Bedford, OH facility is seeking aMaintenance Mechanic, IV Bag Packaging, who will maintain systems and equipment for the sterile, intravenous bag packaging production process. The mechanic is responsible for supporting the process by performing maintenance on all equipment with a high quality mindset, in a safe manner, and within a defined schedule. The mechanic will perform maintenance on equipment and components related to compressed air, electromechanical, controls, electrical, mechanical, instrumentation, vision systems, and robotics. Additionally, the mechanic will be responsible for documenting all actions in equipment logs and a computerized maintenance management system.
Experience and Skills
- Daily responsibility for ensuring that the packaging lines are running stable, in a validated state and with good quality and compliance.
- Perform maintenance assignments, to include routine maintenance, diagnostics, troubleshooting, repair, installation and overhaul of packaging / processing equipment within a pharmaceutical Packaging area.
- Responsible for supporting creation and updating of procedures and set-up's enabling us to improve quality, compliance, processes and stability.
- Work collaboratively with operators to ensure that production is carried out in compliance with procedures to ensure good quality.
- Problem solve and assist in resolving issues on the line.
- Serve as the technical person on the line ensuring the packaging lines are running smoothly.
- Start up and carry out problem solving on the shop-floor involving relevant stakeholders.
- Make certain that equipment is maintained correctly according to the overall plan in line with current pharmaceutical regulatory requirements and anchored in procedures.
- Ensure that spare part stock is adjusted when necessary.
- Guide colleagues in the importance of pro-active behavior in regards to improving the work environment towards zero accidents.
- Ensure processes and products are in compliance with all local, state, and federal rules and regulations. Oversee 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 21CFR Parts 210 and 211, cGMPs, FDA, OSHA and other regulatory agencies.
- Personnel engaged in the manufacture, 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.
- 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.
- 2-3 years related experience required.
- Good technical experience with quality control technology including (vision, mechanics or automation).
- Pharmaceutical or medical device manufacturing experience preferred.
- Prior experience with complex high speed packaging equipment.
- 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 understand, and work with, regulatory requirements such as 21CFR part 210 and 211, cGMP's, FDA, OSHA and other regulatory agencies.
- Knowledge of cGMP requirements preferred with a strong and versatile quality mind-set
We offer a competitive compensation and benefits package with an excellent working environment that is safe and engaging. Leaders are dedicated to your success and support professional and personal growth through various development and training opportunities. If you are looking for a rewarding career, Xellia is the organization for you!
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 here
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